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FDA 510(k)

IRRIGATION/ASPIRATION POLYPECTOMY

K-Number: K970356 · 1997-03-25

ApplicantUnited States Endoscopy Group, Inc.
Decision Date1997-03-25
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/ASPIRATION POLYPECTOMY is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 1997-03-25 under 510(k) number K970356. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION/ASPIRATION POLYPECTOMY?

IRRIGATION/ASPIRATION POLYPECTOMY is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K970356.

When did IRRIGATION/ASPIRATION POLYPECTOMY receive FDA 510(k) clearance?

IRRIGATION/ASPIRATION POLYPECTOMY received FDA 510(k) clearance on 1997-03-25, under 510(k) number K970356.

Who is the listed applicant for IRRIGATION/ASPIRATION POLYPECTOMY?

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

What is the FDA product code for IRRIGATION/ASPIRATION POLYPECTOMY?

The FDA product code for IRRIGATION/ASPIRATION POLYPECTOMY is FDI.

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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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