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FDA 510(k)

AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE

K-Number: K963999 · 1996-11-27

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1996-11-27
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** 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 1996-11-27 under 510(k) number K963999. 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 AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE?

AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K963999.

When did AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE receive FDA 510(k) clearance?

AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE received FDA 510(k) clearance on 1996-11-27, under 510(k) number K963999.

Who is the listed applicant for AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** 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 AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE?

The FDA product code for AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** 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.

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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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