Cleared Traditional

K041321 - VEROSCOPE OPTICAL VERESS CANNULA & DILA...

K041321 is the FDA 510(k) clearance for VEROSCOPE OPTICAL VERESS CANNULA & DILA... by Richard Wolf Medical Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K041321 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
52d
Days
Class 2
Risk

K041321 is an FDA 510(k) clearance for the VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM. 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 July 9, 2004 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K041321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2004
Decision Date July 09, 2004
Days to Decision 52 days
Submission Type Traditional
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
108d faster than avg
Panel avg: 160d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041321.
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169 · Applied Medical Resources Corp. · Aug 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050 · Ethicon, Inc. · Jul 2006
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404 · Intuitive Surgical, Inc. · Apr 2005
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · Applied Medical Resources Corp. · Mar 2004
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · CooperSurgical, Inc. · Apr 2003
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp. · Apr 2001