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FDA 510(k)

TROCAR SLEEVE SYSTEM

K-Number: K770379 · 1977-03-09

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1977-03-09
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROCAR SLEEVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1977-03-09 under 510(k) number K770379. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCAR SLEEVE SYSTEM?

TROCAR SLEEVE SYSTEM is a medical device that received FDA 510(k) clearance on 1977-03-09. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K770379.

When did TROCAR SLEEVE SYSTEM receive FDA 510(k) clearance?

TROCAR SLEEVE SYSTEM received FDA 510(k) clearance on 1977-03-09, under 510(k) number K770379.

Who is the listed applicant for TROCAR SLEEVE SYSTEM?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROCAR SLEEVE SYSTEM?

The FDA product code for TROCAR SLEEVE SYSTEM is HET.

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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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