Reusable Endocavity Needle Guide

FDA UDI

Class II (US FDA UDI)

by Protek Medical Products, Inc.

Identity

Trade Name: Reusable Endocavity Needle Guide FDA UDI
Generic Name: Needle guide, reusable FDA UDI
Device Name: Stainless Steel Reusable Endocavity Needle Guide for Ultrasonix EC9-5/10, Prosonic EC10R and Samsung Medison EV4-9/10ED & ER4-9/10ED Ultrasound Transducers FDA UDI
Model / Reference: 6456 FDA UDI
Description: Stainless Steel Reusable Endocavity Needle Guide for Ultrasonix EC9-5/10, Prosonic EC10R and Samsung Medison EV4-9/10ED & ER4-9/10ED Ultrasound Transducers FDA UDI

Identifiers

Primary DI / UDI-DI: 10841912102669 FDA UDI
510(k) Number: K971115 FDA UDI
K971722 FDA UDI
FDA Product Code: ITX FDA UDI
GMDN Term: Needle guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Needle guide, reusable

Reusable Endocavity Needle Guide by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Needle guide, reusable.

Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
EZU-PA5O-14 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
MP-2794-G16 — FUJIFILM Corporation · Class II
InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II

Cleared under the same submission

K971115 also covers:

K971722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Protek Medical Products, Inc.

Sources (1)

FDA UDI 518e6cae-418f-42f4-8fca-26b2ceb4579e 34 fields · synced May 30, 2026