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VitroPRO

by Civco Medical Instruments Co., Inc. 2 variants

510(k) K231783

VitroPRO is a medical device (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Civco Medical Instruments Co., Inc., cleared under FDA 510(k) K231783 on 14 Nov 2023, 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

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK231783 Date14 Nov 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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 K231783

17 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 K231783
UDI-DISize and differences
Needle Guide 667-187
CIVCO MEDICAL INSTRUMENTS CO., INC.
667-187 / 667-18710841436122655 —On the market
Needle Guide 667-188
CIVCO MEDICAL INSTRUMENTS CO., INC.
667-188, 667-188-5 / 667-18810841436122662 —On the market
Needle Guide 810-400
CIVCO MEDICAL INSTRUMENTS CO., INC.
810-400, 810-400-5 / 810-40010841436123225 —On the market
Needle Guide 810-401
CIVCO MEDICAL INSTRUMENTS CO., INC.
810-401, 810-401-5 / 810-40110841436123249 —On the market
Needle Guide 842-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
842-001, 842-001-5 / 842-00110841436122211 —On the market
Needle Guide 842-002
CIVCO MEDICAL INSTRUMENTS CO., INC.
842-002, 842-002-5 / 842-00210841436122228 —On the market
Needle Guide 842-004
CIVCO MEDICAL INSTRUMENTS CO., INC.
842-004, 842-004-5 / 842-00410841436122242 —On the market
Needle Guide 842-009
CIVCO MEDICAL INSTRUMENTS CO., INC.
842-009, 842-009-5 / 842-00910841436125953 —On the market
Needle Guide 844-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
844-001, 844-001-5 / 844-00110841436122266 —On the market
Needle Guide 857-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
857-001, 857-001-5 / 857-00110841436122273 —On the market
Needle Guide 857-004
CIVCO MEDICAL INSTRUMENTS CO., INC.
857-004, 857-004-5 / 857-00410841436125939 —On the market
Needle Guide 867-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
867-001, 867-001-5 / 867-00110841436122297 —On the market
Needle Guide 867-003
CIVCO MEDICAL INSTRUMENTS CO., INC.
867-003, 867-003-5 / 867-00310841436122310 —On the market
Needle Guide 867-005
CIVCO MEDICAL INSTRUMENTS CO., INC.
867-005, 867-005-5 / 867-00510841436122334 —On the market
Needle Guide 867-010
CIVCO MEDICAL INSTRUMENTS CO., INC.
867-010, 867-010-5 / 867-01010841436125915 —On the market
Needle Guide 876-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
876-001, 867-001-5 / 876-00110841436122358 —On the market
Needle Guide 880-001
CIVCO MEDICAL INSTRUMENTS CO., INC.
880-001, 880-001-5 / 880-00110841436122365 —On the market

Similar devices

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

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →