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FDA 510(k)

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU

K-Number: K964441 · 1997-03-28

ApplicantGynecare Innovation Center
Decision Date1997-03-28
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare Innovation Center. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K964441. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU?

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Gynecare Innovation Center. The 510(k) number is K964441.

When did FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU receive FDA 510(k) clearance?

FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU received FDA 510(k) clearance on 1997-03-28, under 510(k) number K964441.

Who is the listed applicant for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU?

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

What is the FDA product code for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU?

The FDA product code for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU is KNF.

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 Gynecare Innovation Center 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.

K980393SOPRANO CRYO-THERAPY SYSTEMK971305FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEMK964892FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)K963872FEMRX MORCELLATOR SYSTEMK962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]K954775FLO-STAT FLUID MONITORING SYSTEM

View all 8 devices →

Related Devices (Code: KNF)

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.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, 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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