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FDA 510(k)

AUTO SUTURE* ILM** KIT

K-Number: K971201 · 1997-06-03

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-06-03
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* ILM** KIT 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 1997-06-03 under 510(k) number K971201. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE* ILM** KIT?

AUTO SUTURE* ILM** KIT is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K971201.

When did AUTO SUTURE* ILM** KIT receive FDA 510(k) clearance?

AUTO SUTURE* ILM** KIT received FDA 510(k) clearance on 1997-06-03, under 510(k) number K971201.

Who is the listed applicant for AUTO SUTURE* ILM** KIT?

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* ILM** KIT?

The FDA product code for AUTO SUTURE* ILM** KIT is FZP.

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

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Related Devices (Code: FZP)

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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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