Cleared Traditional

K942201 - LAPAROSCOPY DILATION SYSTEM

K942201 is the FDA 510(k) clearance for LAPAROSCOPY DILATION SYSTEM by Richard Wolf Medical Instruments Corp.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K942201 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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May 1994
Decision
20d
Days
Class 2
Risk

K942201 is an FDA 510(k) clearance for the LAPAROSCOPY DILATION SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on May 25, 1994 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 K942201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1994
Decision Date May 25, 1994
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 679
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K942201.
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K933330 · Aesculap, Inc. · Jun 1994
KNOT SLIDE 8383.55 AND 8383.551
K941136 · Richard Wolf Medical Instruments Corp. · Jun 1994
TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940347 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
SUCTION AND IRRIGATION TUBES
K942202 · Richard Wolf Medical Instruments Corp. · May 1994
SUTURE MANIPULATOR
K941286 · Richard Wolf Medical Instruments Corp. · May 1994
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
K935786 · Cabot Medical Corp. · May 1994