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FDA 510(k)

CUTALON NYLON POLYAMIDE SURGICAL SUTURE

K-Number: K981322 · 1998-07-07

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)
Decision Date1998-07-07
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTALON NYLON POLYAMIDE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K981322. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTALON NYLON POLYAMIDE SURGICAL SUTURE?

CUTALON NYLON POLYAMIDE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K981322.

When did CUTALON NYLON POLYAMIDE SURGICAL SUTURE receive FDA 510(k) clearance?

CUTALON NYLON POLYAMIDE SURGICAL SUTURE received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981322.

Who is the listed applicant for CUTALON NYLON POLYAMIDE SURGICAL SUTURE?

The FDA 510(k) record lists Genzyme Surgical Product (Genzyme Biosurgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUTALON NYLON POLYAMIDE SURGICAL SUTURE?

The FDA product code for CUTALON NYLON POLYAMIDE SURGICAL SUTURE is GAR.

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Other records listing Genzyme Surgical Product (Genzyme Biosurgery) 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.

K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTUREK001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREK992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK991416ENDOSCOPIC CAMERAK991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK990062SAPHLIFT

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Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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