Cleared Traditional

K992901 - GYNECARE VERSAPOINT G-VAP ELECTRODE

K992901 is an FDA 510(k) clearance for GYNECARE VERSAPOINT G-VAP ELECTRODE, manufactured by Gynecare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K992901 · Gynecare, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
141d
Days
Class 2
Risk

K992901 is an FDA 510(k) clearance for the GYNECARE VERSAPOINT G-VAP ELECTRODE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gynecare, Inc. (Somerville, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gynecare, Inc. devices

FDA 510(k) Submission Details - K992901

510(k) Number K992901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date January 18, 2000
Days to Decision 141 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 160d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 143
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K992901.
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc. · Aug 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · Richard Wolf Medical Instruments Corp. · May 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · Ethicon, Inc. · Jan 2000
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K993749 · Gyrus Medical , Ltd. · Dec 1999
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
K991563 · Henke Sass Wolf of America, Inc. · Oct 1999
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
K992027 · Karl Storz Endoscopy · Sep 1999