Customed 712057839816

• FDA 510(k) K092338 decided 27 May 2011 Active
• FDA GUDID UDI-DI M20890010918160 listed 23 Sep 2016 Listed

1. 27 May 2011 Cleared FDA 510(k) K092338
2. 23 Sep 2016 Listed FDA GUDID M20890010918160

Trade name

Customed

Generic name

Soft-tissue biopsy needle, single-use

Model / Ref / Catalog

712057839816, 9001091816

Primary DI / UDI-DI

M20890010918160

510(k) Number

K092338 ↗

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

Category: Soft-tissue biopsy needle, single-use

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

• Co-Axial Introducer Needle MCXS1812SX by Argon Medical Devices, Inc.
• SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE by SENORX, INC.
• TRAPSYSTEM SET TRAPJ 0810 by H.S. HOSPITAL SERVICE SPA
• Control Module- Revolve EX CA000606001 MSCM1 by Devicor Medical Products, Inc.
• ENTERON LIVER BIOPSY TRAY by Endovations
• BONE BIOPSY NEEDLE by Promex, Inc.
• Mammotome Revolve CA00006003 MSCM1 by Devicor Medical Products, Inc.
• WILSON-COOK BIOPSY FORCEPS by Wilson-Cook Medical, Inc.
• BMN I TYPE I 1507M by H.S. HOSPITAL SERVICE SPA
• THE AUTO SUTURE* MIBB** SYSTEM by United States Surgical, A Division of Tyco Healthc

• Sterile Suture Removal Kit

  Class I

  FDA 510(k) K925015 Active Cleared 7 Jun 1993

• Customed 712057831816

  Class II

  FDA 510(k) K092338 Active Cleared 27 May 2011 GUDID on market

• Customed 712057102985

  Class I

  GUDID on market

• Customed 712057462213

  Class II

  FDA 510(k) K081633 Active Cleared 11 Aug 2008 GUDID on market

See all devices from Customed, Inc. →