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FDA 510(k)

GYNECARE VERSAPOINT G-VAP ELECTRODE

K-Number: K992901 · 2000-01-18

ApplicantGynecare, Inc.
Decision Date2000-01-18
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECARE VERSAPOINT G-VAP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare, Inc.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K992901. 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 GYNECARE VERSAPOINT G-VAP ELECTRODE?

GYNECARE VERSAPOINT G-VAP ELECTRODE is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Gynecare, Inc.. The 510(k) number is K992901.

When did GYNECARE VERSAPOINT G-VAP ELECTRODE receive FDA 510(k) clearance?

GYNECARE VERSAPOINT G-VAP ELECTRODE received FDA 510(k) clearance on 2000-01-18, under 510(k) number K992901.

Who is the listed applicant for GYNECARE VERSAPOINT G-VAP ELECTRODE?

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 GYNECARE VERSAPOINT G-VAP ELECTRODE?

The FDA product code for GYNECARE VERSAPOINT G-VAP ELECTRODE 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.

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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.

K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)K962482SCUBA 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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