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FDA 510(k)

SURGICAL TISSUE POUCH

K-Number: K910914 · 1991-03-28

ApplicantCook Urological, Inc.
Decision Date1991-03-28
Product CodeKGY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL TISSUE POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1991-03-28 under 510(k) number K910914. The device is classified under product code KGY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL TISSUE POUCH?

SURGICAL TISSUE POUCH is a medical device that received FDA 510(k) clearance on 1991-03-28. The listed applicant is Cook Urological, Inc.. The 510(k) number is K910914.

When did SURGICAL TISSUE POUCH receive FDA 510(k) clearance?

SURGICAL TISSUE POUCH received FDA 510(k) clearance on 1991-03-28, under 510(k) number K910914.

Who is the listed applicant for SURGICAL TISSUE POUCH?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL TISSUE POUCH?

The FDA product code for SURGICAL TISSUE POUCH is KGY.

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Other records listing Cook Urological, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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Related Devices (Code: KGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933085GOODMAN BANDAGEMegadyne Medical Products, Inc.K913678TROCAR CATHETERMedovations, Inc.K832318ISOLATION BAG 3M3M CompanyK801824BAND-AID BRAND FLEXIBLE FABRIC BANDAGEJohnson & Johnson Professionals, Inc.K801823BAND-AID BRAND TRICOT MESH BANDAGESJohnson & Johnson Professionals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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