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FDA 510(k)

GYNEX ELECTRODES

K-Number: K982739 · 1999-03-12

ApplicantGynex Corp.
Decision Date1999-03-12
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNEX ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Gynex Corp.. It received FDA 510(k) clearance on 1999-03-12 under 510(k) number K982739. 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 GYNEX ELECTRODES?

GYNEX ELECTRODES is a medical device that received FDA 510(k) clearance on 1999-03-12. The listed applicant is Gynex Corp.. The 510(k) number is K982739.

When did GYNEX ELECTRODES receive FDA 510(k) clearance?

GYNEX ELECTRODES received FDA 510(k) clearance on 1999-03-12, under 510(k) number K982739.

Who is the listed applicant for GYNEX ELECTRODES?

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

What is the FDA product code for GYNEX ELECTRODES?

The FDA product code for GYNEX ELECTRODES is HGI.

Related Clinical Trials

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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Other records listing Gynex 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.

K061306CO-1000 COLPOSCOPE, MULTIPLEK980238GYNEX EXTENDED REACH NEEDLEK980237GYNEX ENDOSPECULUMK980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

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

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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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