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FDA 510(k)

GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS

K-Number: K970372 · 1997-03-11

ApplicantPrecision Endoscopy of America, Inc.
Decision Date1997-03-11
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS is the device name listed in this FDA 510(k) record. The listed applicant is Precision Endoscopy of America, Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K970372. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS?

GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Precision Endoscopy of America, Inc.. The 510(k) number is K970372.

When did GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS receive FDA 510(k) clearance?

GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS received FDA 510(k) clearance on 1997-03-11, under 510(k) number K970372.

Who is the listed applicant for GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS?

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

What is the FDA product code for GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS?

The FDA product code for GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS is FDF.

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Related Devices (Code: FDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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