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FDA 510(k)

SITE 810E PHOTOCOAGULATOR AND ACCESSORIES

K-Number: K895663 · 1989-12-04

ApplicantSite Microsurgical Systems, Inc.
Decision Date1989-12-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SITE 810E PHOTOCOAGULATOR AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1989-12-04 under 510(k) number K895663. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SITE 810E PHOTOCOAGULATOR AND ACCESSORIES?

SITE 810E PHOTOCOAGULATOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1989-12-04. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K895663.

When did SITE 810E PHOTOCOAGULATOR AND ACCESSORIES receive FDA 510(k) clearance?

SITE 810E PHOTOCOAGULATOR AND ACCESSORIES received FDA 510(k) clearance on 1989-12-04, under 510(k) number K895663.

Who is the listed applicant for SITE 810E PHOTOCOAGULATOR AND ACCESSORIES?

The FDA 510(k) record lists Site Microsurgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SITE 810E PHOTOCOAGULATOR AND ACCESSORIES?

The FDA product code for SITE 810E PHOTOCOAGULATOR AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Site Microsurgical Systems, Inc. as applicant

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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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