Van-Tec Bladder Evacuator

• • Terminated Z-1300-06 FDA Unclassified (pre-2012) ·initiated 30 Jun 2006 ·on shared 510(k) K880099

  Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.

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

510(k) Number

K880099 ↗

FDA Product Code

KQT

Device Class

Class II

Regulation

21 CFR Part 876.4370

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Segura Stone Basket W/Protective Sheath

  Class II

  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Endopyelotomy Knife

  Class I

  FDA 510(k) K880094 Active Cleared 29 Feb 1988

See all devices from Van-Tec, Inc. →