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Customed 712057831816

by Customed, Inc.

Customed 712057831816 (9000991816) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K092338 on 27 May 2011 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890009918160), 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) K092338

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 NumberM20890009918160 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092338 Date27 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092338 decided 27 May 2011 Active
  • FDA GUDID UDI-DI M20890009918160 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092338
  2. Listed FDA GUDID M20890009918160

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Customed
Generic name
Soft-tissue biopsy needle, single-use
Model / Ref / Catalog
712057831816, 9000991816
Primary DI / UDI-DI
M20890009918160
510(k) Number
FDA product code
KNW
GMDN term
Soft-tissue biopsy needle, single-use
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Length — 160 Millimeter
Needle Gauge — 18 Gauge

Related devices

Category: Soft-tissue biopsy needle, single-use

Cleared under the same submission (K092338)

and 8 more cleared under K092338

Similar devices

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

Other devices from Customed, Inc.

See all devices from Customed, Inc. →

Properties

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