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FDA 510(k)

VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)

K-Number: K982738 · 1999-03-01

ApplicantGynecare, Inc.
Decision Date1999-03-01
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare, Inc.. It received FDA 510(k) clearance on 1999-03-01 under 510(k) number K982738. 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 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)?

VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is Gynecare, Inc.. The 510(k) number is K982738.

When did VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) receive FDA 510(k) clearance?

VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) received FDA 510(k) clearance on 1999-03-01, under 510(k) number K982738.

Who is the listed applicant for VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)?

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

What is the FDA product code for VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)?

The FDA product code for VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) is HIH.

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, Inc. 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.

K992901GYNECARE VERSAPOINT G-VAP ELECTRODEK962482SCUBA SYSTEM

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

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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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