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FDA 510(k)

AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE

K-Number: K042897 · 2004-11-19

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2004-11-19
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042897. 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 AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE?

AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K042897.

When did AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE receive FDA 510(k) clearance?

AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042897.

Who is the listed applicant for AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE?

The FDA product code for AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE is GAL.

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Other records listing Ethicon Endo-Surgery, 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.

K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADSK110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERK101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHK102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLERK093896ETHICON ENDO SURGERY SLOTTED ANOSCOPEK091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS

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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.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLCK011105SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICEQrc Consulting

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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