Cleared Special

K003417 - MINI FIBER ENDOSCOPES

Also marketed or referenced as:
OUTER SHEATHS VERESS CANNULAS VERESS CANNULAS WITH OUTER SHEATHS, SET

K003417 is the FDA 510(k) clearance for MINI FIBER ENDOSCOPES by Richard Wolf Medical Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Special 510(k) pathway after a 153-day FDA review.

K003417 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
153d
Days
Class 2
Risk

K003417 is an FDA 510(k) clearance for the MINI FIBER ENDOSCOPES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 4, 2001 after a review of 153 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K003417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2000
Decision Date April 04, 2001
Days to Decision 153 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
7d faster than avg
Panel avg: 160d · This submission: 153d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 150
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K003417.
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · Richard Wolf Medical Instruments Corp. · Jul 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · Applied Medical Resources Corp. · Mar 2004
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · CooperSurgical, Inc. · Apr 2003
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp. · Jan 2001
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · Xomed, Inc. · Jun 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · Ethicon Endo-Surgery, Inc. · May 2000