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VanishPoint® 10154

by Retractable Technologies, Inc.

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) K980069

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613703101532 UDI-DI Date16 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK980069 Date12 Feb 1998IssuedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Metered-delivery hypodermic syringe/needle
Model / Ref / Catalog
10154
Primary DI / UDI-DI
00613703101532
510(k) Number
FDA product code
MEG
GMDN term
Metered-delivery hypodermic syringe/needle
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K980069)

Other devices from Retractable Technologies, Inc.

See all devices from Retractable Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No