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Inrad 54501

by Inrad

Inrad 54501 is a Class II device made by Inrad, cleared under FDA 510(k) K913098 on 5 Nov 1991 and listed in FDA GUDID since 9 Oct 2026 (UDI-DI 00817295020589), 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) K913098

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 Number00817295020589 UDI-DI Date9 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK913098 Date5 Nov 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K913098 decided 5 Nov 1991 Active
  • FDA GUDID UDI-DI 00817295020589 listed 9 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K913098
  2. Listed FDA GUDID 00817295020589

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  • Withdrawn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
Biopsy syringe holder, reusable
Model / Ref / Catalog
54501
Primary DI / UDI-DI
00817295020589
510(k) Number
FDA product code
KNW
GMDN term
Biopsy syringe holder, reusable
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution

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

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)