Cleared Special

K003417 - MINI FIBER ENDOSCOPES

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

K003417 is an FDA 510(k) clearance for MINI FIBER ENDOSCOPES, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K003417

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
8d faster than avg
Panel avg: 161d · This submission: 153d
Pathway characteristics
Modification to existing cleared device.

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 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K003417.
VASOVIEW 5 HARVESTING CANNULA
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GYNECOLOGICAL LAPAROSCOPES
K003805 · Global Endoscopy, Inc. · Jul 2001
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · A & A Medical, Inc. · May 2001
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
K003417 · MINI FIBER ENDOSCOPES
Download PDF FDA Summary Richard Wolf Medical …