FDA 510(k)

ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS

K-Number: K033421 · 2004-10-14

Decision Date2004-10-14

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2004-10-14 under 510(k) number K033421. 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 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS?

ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Erbe USA, Inc.. The 510(k) number is K033421.

When did ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS received FDA 510(k) clearance on 2004-10-14, under 510(k) number K033421.

Who is the listed applicant for ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS?

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

What is the FDA product code for ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS?

The FDA product code for ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.