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FDA 510(k)

ENDOBOOT

K-Number: K951104 · 1995-04-06

ApplicantUnited States Endoscopy Group, Inc.
Decision Date1995-04-06
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOBOOT 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 1995-04-06 under 510(k) number K951104. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOBOOT?

ENDOBOOT is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K951104.

When did ENDOBOOT receive FDA 510(k) clearance?

ENDOBOOT received FDA 510(k) clearance on 1995-04-06, under 510(k) number K951104.

Who is the listed applicant for ENDOBOOT?

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 ENDOBOOT?

The FDA product code for ENDOBOOT is OCU.

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Related Devices (Code: OCU)

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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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