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FDA 510(k)

ACCESSORIES FOR SYS. 400 CO2 SURG. LASER

K-Number: K791895 · 1979-12-20

ApplicantCoherent Medical Division
Decision Date1979-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCESSORIES FOR SYS. 400 CO2 SURG. LASER is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Division. It received FDA 510(k) clearance on 1979-12-20 under 510(k) number K791895. 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 ACCESSORIES FOR SYS. 400 CO2 SURG. LASER?

ACCESSORIES FOR SYS. 400 CO2 SURG. LASER is a medical device that received FDA 510(k) clearance on 1979-12-20. The listed applicant is Coherent Medical Division. The 510(k) number is K791895.

When did ACCESSORIES FOR SYS. 400 CO2 SURG. LASER receive FDA 510(k) clearance?

ACCESSORIES FOR SYS. 400 CO2 SURG. LASER received FDA 510(k) clearance on 1979-12-20, under 510(k) number K791895.

Who is the listed applicant for ACCESSORIES FOR SYS. 400 CO2 SURG. LASER?

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

What is the FDA product code for ACCESSORIES FOR SYS. 400 CO2 SURG. LASER?

The FDA product code for ACCESSORIES FOR SYS. 400 CO2 SURG. LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Coherent Medical Division as applicant

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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Related Devices (Code: GEX)

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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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