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FDA 510(k)

SUTURE ABSORBABLE- GUT

K-Number: K932037 · 1994-01-07

ApplicantSurgical Specialties, Inc.
Decision Date1994-01-07
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE ABSORBABLE- GUT is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K932037. 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 SUTURE ABSORBABLE- GUT?

SUTURE ABSORBABLE- GUT is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Surgical Specialties, Inc.. The 510(k) number is K932037.

When did SUTURE ABSORBABLE- GUT receive FDA 510(k) clearance?

SUTURE ABSORBABLE- GUT received FDA 510(k) clearance on 1994-01-07, under 510(k) number K932037.

Who is the listed applicant for SUTURE ABSORBABLE- GUT?

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

What is the FDA product code for SUTURE ABSORBABLE- GUT?

The FDA product code for SUTURE ABSORBABLE- GUT is GAR.

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Other records listing Surgical Specialties, 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.

K930826SUTURE NONABSORBABLE - SILKK932038SUTURE NONABSORBABLE- SILK, POLYESTERK930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESK874219S3 MEDICATED GAUZEK861445S1 CAVITY PACKINGK861444S1 NASAL PACKING

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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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