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FDA 510(k)

ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER

K-Number: K873773 · 1987-10-13

ApplicantHgm, Inc.
Decision Date1987-10-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1987-10-13 under 510(k) number K873773. 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 ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER?

ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER is a medical device that received FDA 510(k) clearance on 1987-10-13. The listed applicant is Hgm, Inc.. The 510(k) number is K873773.

When did ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER receive FDA 510(k) clearance?

ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER received FDA 510(k) clearance on 1987-10-13, under 510(k) number K873773.

Who is the listed applicant for ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER?

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

What is the FDA product code for ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER?

The FDA product code for ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm, Inc. 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.

K950120SMART PLUGK931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEK931784HGM ILLUMINATING IMAGING ENDOCULAR PROBEK933333HGM SCANMAN PLUSK931499Q-11 OPHTHALMIC LASERK925663HGM ASPIRATING ENDOOCULAR(TM) PROBE

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Related Devices (Code: GEX)

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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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