Cleared Traditional

K963872 - FEMRX MORCELLATOR SYSTEM

K963872 is an FDA 510(k) clearance for FEMRX MORCELLATOR SYSTEM, manufactured by Gynecare Innovation Center. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K963872 · Gynecare Innovation Center · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
113d
Days
Class 2
Risk

K963872 is an FDA 510(k) clearance for the FEMRX MORCELLATOR SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gynecare Innovation Center (Sunnyvale, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Innovation Center devices

FDA 510(k) Submission Details - K963872

510(k) Number K963872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date January 17, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 160d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K963872.
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K970105 · Richard Wolf Medical Instruments Corp. · Mar 1997
KSEA PUNCTURE CANNULA
K964379 · KARL STORZ Endoscopy-America, Inc. · Jan 1997
KSEA UNIMAT PLUS
K963960 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
KSEA UNIMAT PLUS
K963949 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
K960299 · Richard Wolf Medical Instruments Corp. · Oct 1996