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Inrad 621516

by Inrad

Inrad 621516 is a Class II device made by Inrad, cleared under FDA 510(k) K000612 on 24 Apr 2000 and listed in FDA GUDID since 8 Oct 2026 (UDI-DI 00817295021111), 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) K000612

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 Number00817295021111 UDI-DI Date8 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000612 Date24 Apr 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000612 decided 24 Apr 2000 Active
  • FDA GUDID UDI-DI 00817295021111 listed 8 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000612
  2. Listed FDA GUDID 00817295021111

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inrad
Generic name
End-cut biopsy gun handpiece/needle
Model / Ref / Catalog
621516
Primary DI / UDI-DI
00817295021111
510(k) Number
FDA product code
KNW, FCG
GMDN term
End-cut biopsy gun handpiece/needle
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K000612)

and 7 more cleared under K000612

Similar devices

Other devices filed under FDA product code KNW (Instrument, Biopsy).

Other devices from Inrad

  • Inrad 53220

    Class I

  • Inrad 53222

    Class I

  • Inrad 53218

    Class I

  • Inrad 41222

    Class I

See all devices from Inrad →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)