FDA 510(k)

MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

K-Number: K911160 · 1991-05-02

Decision Date1991-05-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1991-05-02 under 510(k) number K911160. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305?

MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 is a medical device that received FDA 510(k) clearance on 1991-05-02. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K911160.

When did MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 receive FDA 510(k) clearance?

MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 received FDA 510(k) clearance on 1991-05-02, under 510(k) number K911160.

Who is the listed applicant for MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305?

The FDA 510(k) record lists Mentor O & O, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305?

The FDA product code for MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 is GEI.

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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.