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FDA 510(k)

FEMRX OPERASTAR SYSTEM

K-Number: K954648 · 1996-03-14

ApplicantGynecare Innovation Center
Decision Date1996-03-14
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMRX OPERASTAR SYSTEM 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 1996-03-14 under 510(k) number K954648. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMRX OPERASTAR SYSTEM?

FEMRX OPERASTAR SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-14. The listed applicant is Gynecare Innovation Center. The 510(k) number is K954648.

When did FEMRX OPERASTAR SYSTEM receive FDA 510(k) clearance?

FEMRX OPERASTAR SYSTEM received FDA 510(k) clearance on 1996-03-14, under 510(k) number K954648.

Who is the listed applicant for FEMRX OPERASTAR SYSTEM?

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 OPERASTAR SYSTEM?

The FDA product code for FEMRX OPERASTAR SYSTEM is HIH.

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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 SYSTEMK964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSUK964892FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)K963872FEMRX MORCELLATOR SYSTEMK962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]

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Related Devices (Code: HIH)

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.

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

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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