Cleared Special

K040302 - VERSAPOINT RESECTOSCOPIC SYSTEM

K040302 is an FDA 510(k) clearance for VERSAPOINT RESECTOSCOPIC SYSTEM, manufactured by Gynecare, A Div. of Ethicon, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Special 510(k) pathway after a 29-day FDA review.

K040302 · Gynecare, A Div. of Ethicon, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
29d
Days
Class 2
Risk

K040302 is an FDA 510(k) clearance for the VERSAPOINT RESECTOSCOPIC SYSTEM. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gynecare, A Div. of Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 9, 2004 after a review of 29 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.

FDA 510(k) Submission Details - K040302

510(k) Number K040302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date March 09, 2004
Days to Decision 29 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
132d faster than avg
Panel avg: 161d · This submission: 29d
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 174
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K040302.
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
K053583 · Optivia Medical, LLC · Mar 2006
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy · May 2004
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
K033113 · Richard Wolf Medical Instruments Corp. · Dec 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · Smith & Nephew, Inc. · Dec 2003
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
K031974 · Asap Endoscopic Products GmbH · Sep 2003
K040302 · VERSAPOINT RESECTOSCOPIC SYSTEM
Download PDF FDA Summary Gynecare, A Div. of E…