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FDA 510(k)

AUTO SUTURE LAPAROSCOPES DEVICE

K-Number: K983293 · 1998-12-16

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1998-12-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE LAPAROSCOPES 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 1998-12-16 under 510(k) number K983293. 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 LAPAROSCOPES DEVICE?

AUTO SUTURE LAPAROSCOPES DEVICE is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K983293.

When did AUTO SUTURE LAPAROSCOPES DEVICE receive FDA 510(k) clearance?

AUTO SUTURE LAPAROSCOPES DEVICE received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983293.

Who is the listed applicant for AUTO SUTURE LAPAROSCOPES 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 LAPAROSCOPES DEVICE?

The FDA product code for AUTO SUTURE LAPAROSCOPES DEVICE is GCJ.

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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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