SURGICAL TISSUE POUCH— 510(k) K910914

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K910914 for SURGICAL TISSUE POUCH, Substantially Equivalent on 1991-03-28. Applicant: Cook Urological, Inc.. Device class: 1.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KGY
Device class: Class 1
Regulation: 21 CFR 878.4100
Advisory panel: General, Plastic Surgery
Date received: 1991-03-05
Decision date: 1991-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGY

K933085 — GOODMAN BANDAGE1993-12-23
K913678 — TROCAR CATHETER1991-12-16
K832318 — ISOLATION BAG 3M1983-10-31
K801823 — BAND-AID BRAND TRICOT MESH BANDAGES1980-08-20
K801824 — BAND-AID BRAND FLEXIBLE FABRIC BANDAGE1980-08-20

More clearances from Cook Urological, Inc.

K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)2011-05-06
K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER2009-10-09
K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-1224002009-09-03
K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER2008-11-07
K082536 — COOK WIRE GUIDES2008-10-27

Recalls naming K910914

K-number listed on FDA's recall record

Z-1830-2015 — LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.Class II·Terminated·Cook Inc.·20150514

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K910914.

Data sourced from openFDA. This site is unofficial and independent of the FDA.