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FDA 510(k)

ELECTROSURGICAL GENERATOR MODEL ESU100/250/550

K-Number: K914367 · 1992-04-28

ApplicantGyne-Tech Instrument Corp.
Decision Date1992-04-28
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 is the device name listed in this FDA 510(k) record. The listed applicant is Gyne-Tech Instrument Corp.. It received FDA 510(k) clearance on 1992-04-28 under 510(k) number K914367. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGICAL GENERATOR MODEL ESU100/250/550?

ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Gyne-Tech Instrument Corp.. The 510(k) number is K914367.

When did ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 receive FDA 510(k) clearance?

ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 received FDA 510(k) clearance on 1992-04-28, under 510(k) number K914367.

Who is the listed applicant for ELECTROSURGICAL GENERATOR MODEL ESU100/250/550?

The FDA 510(k) record lists Gyne-Tech Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROSURGICAL GENERATOR MODEL ESU100/250/550?

The FDA product code for ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 is HGI.

Related Clinical Trials

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Other records listing Gyne-Tech Instrument Corp. 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.

K954911OMEGA ULTRASCANK922878MODEL GT1ST CRYOSURGICAL INSTRUMENT

Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, Inc.

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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