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FDA 510(k)

GELBFISH ENDO-VAC SYSTEM

K-Number: K970233 · 1997-10-08

ApplicantGary A. Gelbfish
Decision Date1997-10-08
Product CodeMCW
Advisory CommitteeCV
DecisionUnknown

Device Summary

GELBFISH ENDO-VAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gary A. Gelbfish. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K970233. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GELBFISH ENDO-VAC SYSTEM?

GELBFISH ENDO-VAC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Gary A. Gelbfish. The 510(k) number is K970233.

When did GELBFISH ENDO-VAC SYSTEM receive FDA 510(k) clearance?

GELBFISH ENDO-VAC SYSTEM received FDA 510(k) clearance on 1997-10-08, under 510(k) number K970233.

Who is the listed applicant for GELBFISH ENDO-VAC SYSTEM?

The FDA 510(k) record lists Gary A. Gelbfish as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELBFISH ENDO-VAC SYSTEM?

The FDA product code for GELBFISH ENDO-VAC SYSTEM is MCW.

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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.

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