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FDA 510(k)

AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP

K-Number: K904588 · 1990-12-24

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1990-12-24
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP 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 1990-12-24 under 510(k) number K904588. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP?

AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP is a medical device that received FDA 510(k) clearance on 1990-12-24. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K904588.

When did AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP receive FDA 510(k) clearance?

AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP received FDA 510(k) clearance on 1990-12-24, under 510(k) number K904588.

Who is the listed applicant for AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP?

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 AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP?

The FDA product code for AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP 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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