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FDA 510(k)

GYNEX ENDOSPECULUM

K-Number: K980237 · 1998-04-08

ApplicantGynex Corp.
Decision Date1998-04-08
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNEX ENDOSPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Gynex Corp.. It received FDA 510(k) clearance on 1998-04-08 under 510(k) number K980237. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNEX ENDOSPECULUM?

GYNEX ENDOSPECULUM is a medical device that received FDA 510(k) clearance on 1998-04-08. The listed applicant is Gynex Corp.. The 510(k) number is K980237.

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

GYNEX ENDOSPECULUM received FDA 510(k) clearance on 1998-04-08, under 510(k) number K980237.

Who is the listed applicant for GYNEX ENDOSPECULUM?

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 ENDOSPECULUM?

The FDA product code for GYNEX ENDOSPECULUM is KNA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, MULTIPLEK982739GYNEX ELECTRODESK980238GYNEX EXTENDED REACH NEEDLEK980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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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