Trans Vaginal Needle Guide

510(k) K971722

Trans Vaginal Needle Guide is a medical device (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Protek Medical Products, Inc., cleared under FDA 510(k) K971722 on 10 Jul 1997, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K971722↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK971722	Date10 Jul 1997Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K971722

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K971722
FDA product code: ITX

Device class: Class II
Regulation: 21 CFR Part 892.1570
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

Devices cleared under K971722

118 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K971722
		UDI-DI	Size and differences
Disposable Needle Guide 5055 PROTEK MEDICAL PRODUCTS, INC.	5055	20841912104059	Prescription: no; Single use: yes	On the market
Disposable Needle Guide 5070 PROTEK MEDICAL PRODUCTS, INC.	5070	10841912105875	Prescription: no; Single use: yes	On the market
Disposable Needle Guide 5145 PROTEK MEDICAL PRODUCTS, INC.	5145	10841912104939	Prescription: no; Single use: yes	On the market
Disposable Needle Guide 5250 PROTEK MEDICAL PRODUCTS, INC.	5250	10841912104915	Prescription: no; Single use: yes	On the market
Disposable Needle Guide 5560 PROTEK MEDICAL PRODUCTS, INC.	5560 / 5560	10841912105943	Prescription: no; Single use: yes	On the market
Reusable (Short Style) Stainless Steel Endocavity Needle Guide 6390 PROTEK MEDICAL PRODUCTS, INC.	6390	10841912102607	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6019 PROTEK MEDICAL PRODUCTS, INC.	6019	10841912102416	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6026 PROTEK MEDICAL PRODUCTS, INC.	6026	10841912102423	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6043 PROTEK MEDICAL PRODUCTS, INC.	6043	10841912102447	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6095 PROTEK MEDICAL PRODUCTS, INC.	6095	10841912102485	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6097 PROTEK MEDICAL PRODUCTS, INC.	6097	10841912105226	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6131 PROTEK MEDICAL PRODUCTS, INC.	6131	10841912102508	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6174 PROTEK MEDICAL PRODUCTS, INC.	6174	10841912104427	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6182 PROTEK MEDICAL PRODUCTS, INC.	6182	10841912106209	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6190 PROTEK MEDICAL PRODUCTS, INC.	6190	00841912106707	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6191 PROTEK MEDICAL PRODUCTS, INC.	6191	00841912104208	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6341 PROTEK MEDICAL PRODUCTS, INC.	6341	10841912102546	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6449 PROTEK MEDICAL PRODUCTS, INC.	6449	10841912102645	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6455 PROTEK MEDICAL PRODUCTS, INC.	6455	10841912102652	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6467 PROTEK MEDICAL PRODUCTS, INC.	6467	10841912102690	Prescription: yes; Single use: no	On the market
Reusable Stainless Steel Endocavity Needle Guide 6531 PROTEK MEDICAL PRODUCTS, INC.	6531	10841912102744	Prescription: yes; Single use: no	On the market
Sterile Disposable Endocavity Needle Guide / System Drape Kit 5280 PROTEK MEDICAL PRODUCTS, INC.	590-03001-00 / 5280	00841912104963	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5260 PROTEK MEDICAL PRODUCTS, INC.	5260 / 5260	00841912105120	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5281 PROTEK MEDICAL PRODUCTS, INC.	590-01002-00 / 5281	00841912106127	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5295 PROTEK MEDICAL PRODUCTS, INC.	5295 / 5295	00841912105724	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5370 PROTEK MEDICAL PRODUCTS, INC.	5370 / 5370	00841912104871	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5455 PROTEK MEDICAL PRODUCTS, INC.	5455 / 5455	00841912107100	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5480 PROTEK MEDICAL PRODUCTS, INC.	5480 / 5480	00841912105748	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5565 PROTEK MEDICAL PRODUCTS, INC.	5565 / 5565	00841912106615	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5575 PROTEK MEDICAL PRODUCTS, INC.	5575 / 5575	00841912105755	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5585 PROTEK MEDICAL PRODUCTS, INC.	5585 / 5585	00841912105762	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5590 PROTEK MEDICAL PRODUCTS, INC.	5590 / 5590	00841912106011	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5650 PROTEK MEDICAL PRODUCTS, INC.	5650 / 5650	00841912105083	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5655 PROTEK MEDICAL PRODUCTS, INC.	5655 / 5655	00841912105892	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 5665 PROTEK MEDICAL PRODUCTS, INC.	5665 / 5665	00841912106387	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide 9002 PROTEK MEDICAL PRODUCTS, INC.	9002 / 9002	00841912101825	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5179 PROTEK MEDICAL PRODUCTS, INC.	5179 / 5179	00841912105359	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5252 PROTEK MEDICAL PRODUCTS, INC.	5252 / 5252	00841912106073	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5261 PROTEK MEDICAL PRODUCTS, INC.	5261 / 5261	00841912105137	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5263 PROTEK MEDICAL PRODUCTS, INC.	5263 / 5263	00841912105151	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5273 PROTEK MEDICAL PRODUCTS, INC.	5273 / 5273	00841912105212	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5280 PROTEK MEDICAL PRODUCTS, INC.	5280	00841912104659	Prescription: yes; Single use: yes	No longer on the market
Sterile Disposable Endocavity Needle Guide Kit 5371 PROTEK MEDICAL PRODUCTS, INC.	5371 / 5371	00841912105168	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5388 PROTEK MEDICAL PRODUCTS, INC.	5388 / 5388	00841912106462	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5535 PROTEK MEDICAL PRODUCTS, INC.	5535 / 5535	00841912106349	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5552 PROTEK MEDICAL PRODUCTS, INC.	5552 / 5552	00841912104994	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5562 PROTEK MEDICAL PRODUCTS, INC.	5562 / 5562	00841912105274	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5563 PROTEK MEDICAL PRODUCTS, INC.	5563 / 5563	00841912105304	Prescription: yes; Single use: yes	On the market
Sterile Disposable Endocavity Needle Guide Kit 5652 PROTEK MEDICAL PRODUCTS, INC.	5652 / 5652	00841912105106	Prescription: yes; Single use: yes	On the market
Sterile Disposable Needle Guide 5045 PROTEK MEDICAL PRODUCTS, INC.	5045 / 5045	00841912101498	Prescription: yes; Single use: yes	On the market

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Protek Medical Products, Inc.

Sterile Single-Use Probe Cover Kit 1090

Class II
Sterile Disposable Endocavity Needle Guide Kit 5253

Class II
Biopsy Starter Kit 7257

Not classified
Reusable Multi Angle Biospy Bracket 6158

Class II

See all devices from Protek Medical Products, Inc. →

Regulatory status

Coverage

Specification

Devices cleared under K971722

Similar devices

Other devices from Protek Medical Products, Inc.

Sterile Single-Use Probe Cover Kit 1090

Sterile Disposable Endocavity Needle Guide Kit 5253

Biopsy Starter Kit 7257

Reusable Multi Angle Biospy Bracket 6158