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FDA 510(k)

AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE

K-Number: K935762 · 1994-01-31

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-01-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE 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 1994-01-31 under 510(k) number K935762. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE?

AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K935762.

When did AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE receive FDA 510(k) clearance?

AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE received FDA 510(k) clearance on 1994-01-31, under 510(k) number K935762.

Who is the listed applicant for AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE?

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 DISPOSABLE ENDOSCOPIC SUTURE NEEDLE?

The FDA product code for AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE is GCJ.

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

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Related Devices (Code: GCJ)

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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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