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Q2 High Flow Stopcock STV01

by Quest Medical Inc

Q2 High Flow Stopcock STV01 (9652) is a Class II device made by Quest Medical Inc, cleared under FDA 510(k) K061143 on 10 May 2006 and listed in FDA GUDID since 12 May 2021 (UDI-DI 00634624911017), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K061143

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634624911017 UDI-DI Date12 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061143 Date10 May 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061143 decided 10 May 2006 Active
  • FDA GUDID UDI-DI 00634624911017 listed 12 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061143
  2. Listed FDA GUDID 00634624911017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Q2 High Flow Stopcock
Generic name
Stopcock
Model / Ref / Catalog
STV01, 9652
Primary DI / UDI-DI
00634624911017
510(k) Number
FDA product code
FMG
GMDN term
Stopcock
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Stopcock.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)