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VanishPoint® 22701

by Retractable Technologies, Inc.

VanishPoint® 22701 is a Class II device made by Retractable Technologies, Inc., cleared under FDA 510(k) K971763 on 26 Aug 1997 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00613703227010), 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) K971763

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 Number00613703227010 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK971763 Date26 Aug 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K971763 decided 26 Aug 1997 Active
  • FDA GUDID UDI-DI 00613703227010 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K971763
  2. Listed FDA GUDID 00613703227010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VanishPoint®
Generic name
Blood collection tube holder, single-use
Model / Ref / Catalog
22701
Primary DI / UDI-DI
00613703227010
510(k) Number
FDA product code
FMI
GMDN term
Blood collection tube holder, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

Other devices from Retractable Technologies, Inc.

See all devices from Retractable Technologies, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)