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FDA 510(k)

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT

K-Number: K935434 · 1994-05-27

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1994-05-27
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT 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 1994-05-27 under 510(k) number K935434. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT?

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K935434.

When did OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT receive FDA 510(k) clearance?

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT received FDA 510(k) clearance on 1994-05-27, under 510(k) number K935434.

Who is the listed applicant for OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT?

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 OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT?

The FDA product code for OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT is LKF.

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Related Devices (Code: LKF)

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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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