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FDA 510(k)

AUTOSUTURE ENDOSCOPIC SUTURING DEVICE

K-Number: K934738 · 1994-03-16

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-03-16
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOSUTURE ENDOSCOPIC SUTURING DEVICE 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 1994-03-16 under 510(k) number K934738. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSUTURE ENDOSCOPIC SUTURING DEVICE?

AUTOSUTURE ENDOSCOPIC SUTURING DEVICE is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K934738.

When did AUTOSUTURE ENDOSCOPIC SUTURING DEVICE receive FDA 510(k) clearance?

AUTOSUTURE ENDOSCOPIC SUTURING DEVICE received FDA 510(k) clearance on 1994-03-16, under 510(k) number K934738.

Who is the listed applicant for AUTOSUTURE ENDOSCOPIC SUTURING DEVICE?

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 AUTOSUTURE ENDOSCOPIC SUTURING DEVICE?

The FDA product code for AUTOSUTURE ENDOSCOPIC SUTURING DEVICE is OCW.

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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: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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