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FDA 510(k)

ABSORBABLE SURGICAL GUT SUTURE*

K-Number: K885018 · 1989-08-22

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1989-08-22
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

ABSORBABLE SURGICAL GUT SUTURE* is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1989-08-22 under 510(k) number K885018. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ABSORBABLE SURGICAL GUT SUTURE*?

ABSORBABLE SURGICAL GUT SUTURE* is a medical device that received FDA 510(k) clearance on 1989-08-22. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K885018.

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

ABSORBABLE SURGICAL GUT SUTURE* received FDA 510(k) clearance on 1989-08-22, under 510(k) number K885018.

Who is the listed applicant for ABSORBABLE SURGICAL GUT SUTURE*?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSORBABLE SURGICAL GUT SUTURE*?

The FDA product code for ABSORBABLE SURGICAL GUT SUTURE* is GAL.

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Other records listing United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

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Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC

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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