Cleared Special

K994418 - VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)

K994418 is an FDA 510(k) clearance for VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA), manufactured by Ethicon, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Special 510(k) pathway after a 26-day FDA review.

K994418 · Ethicon, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
26d
Days
Class 2
Risk

K994418 is an FDA 510(k) clearance for the VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA). Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 24, 2000 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ethicon, Inc. devices

FDA 510(k) Submission Details - K994418

510(k) Number K994418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1999
Decision Date January 24, 2000
Days to Decision 26 days
Submission Type Special
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
134d faster than avg
Panel avg: 160d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K994418.
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc. · Jan 2002
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
GYNECARE VERSAPOINT G-VAP ELECTRODE
K992901 · Gynecare, 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