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FDA 510(k)

BIPOLAR COAGULATOR #9620/9621

K-Number: K823184 · 1982-12-03

ApplicantConcept, Inc.
Decision Date1982-12-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR COAGULATOR #9620/9621 is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823184. 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 BIPOLAR COAGULATOR #9620/9621?

BIPOLAR COAGULATOR #9620/9621 is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Concept, Inc.. The 510(k) number is K823184.

When did BIPOLAR COAGULATOR #9620/9621 receive FDA 510(k) clearance?

BIPOLAR COAGULATOR #9620/9621 received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823184.

Who is the listed applicant for BIPOLAR COAGULATOR #9620/9621?

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

What is the FDA product code for BIPOLAR COAGULATOR #9620/9621?

The FDA product code for BIPOLAR COAGULATOR #9620/9621 is GEI.

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Other records listing Concept, Inc. as applicant

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K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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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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