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FDA 510(k)

ERBE HYBRID KNIFE

K-Number: K083608 · 2009-08-26

ApplicantErbe USA, Inc.
Decision Date2009-08-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBE HYBRID KNIFE 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 2009-08-26 under 510(k) number K083608. 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 HYBRID KNIFE?

ERBE HYBRID KNIFE is a medical device that received FDA 510(k) clearance on 2009-08-26. The listed applicant is Erbe USA, Inc.. The 510(k) number is K083608.

When did ERBE HYBRID KNIFE receive FDA 510(k) clearance?

ERBE HYBRID KNIFE received FDA 510(k) clearance on 2009-08-26, under 510(k) number K083608.

Who is the listed applicant for ERBE HYBRID KNIFE?

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 HYBRID KNIFE?

The FDA product code for ERBE HYBRID KNIFE 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.

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