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FDA 510(k)

ENDOSCOPIC SCLEROTHERAPY BALLOON

K-Number: K821999 · 1982-08-27

ApplicantRetech
Decision Date1982-08-27
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC SCLEROTHERAPY BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Retech. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K821999. The device is classified under product code GCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC SCLEROTHERAPY BALLOON?

ENDOSCOPIC SCLEROTHERAPY BALLOON is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Retech. The 510(k) number is K821999.

When did ENDOSCOPIC SCLEROTHERAPY BALLOON receive FDA 510(k) clearance?

ENDOSCOPIC SCLEROTHERAPY BALLOON received FDA 510(k) clearance on 1982-08-27, under 510(k) number K821999.

Who is the listed applicant for ENDOSCOPIC SCLEROTHERAPY BALLOON?

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

What is the FDA product code for ENDOSCOPIC SCLEROTHERAPY BALLOON?

The FDA product code for ENDOSCOPIC SCLEROTHERAPY BALLOON is GCP.

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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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