Hulka Clips 4986.90

• • Terminated Z-0037-2015 FDA Class II ·initiated 9 Jul 2014

  Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.

• • Terminated Z-0272-2010 FDA Unclassified (pre-2012) ·initiated 16 Oct 2009 ·on shared PMA P870080

  The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Hulka Clips

Generic Name

Fallopian tube clip/band

Model / Ref / Catalog

4986.90, 4986.09

Primary DI / UDI-DI

00861523000102

PMA Number

P870080 ↗

FDA Product Code

KNH

GMDN Term

Fallopian tube clip/band

Device Class

Class III

Regulation Number

884.5380

GUDID distribution status

Not in Commercial Distribution

• Suction and Irrigation Tubes

  Class II

  FDA 510(k) K940960 Active Cleared 8 Nov 1994

• Needle, Spray

  Class II

  FDA 510(k) K770710 Active Cleared 26 Apr 1977

• Trocars Trotec with Automatic Protective Mechanism

  Class II

  FDA 510(k) K003164 Active Cleared 8 Jan 2001

• Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories

  Class II

  FDA 510(k) K042523 Active Cleared 18 Mar 2005

• Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector

  Class II

  FDA 510(k) K972927 Active Cleared 6 Nov 1997

• Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

  Class II

  FDA 510(k) K051176 Active Cleared 5 Oct 2005

See all devices from Richard Wolf Medical Instruments Corp. →