Cleared Traditional

K941222 - OPEN LAPAROSCOPY TROCAR CONE SYSTEM

K941222 is the FDA 510(k) clearance for OPEN LAPAROSCOPY TROCAR CONE 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 310-day FDA review.

K941222 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Jan 1995
Decision
310d
Days
Class 2
Risk

K941222 is an FDA 510(k) clearance for the OPEN LAPAROSCOPY TROCAR CONE 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 January 18, 1995 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K941222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date January 18, 1995
Days to Decision 310 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
195d slower than avg
Panel avg: 115d · This submission: 310d
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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K941222.
MINI LAPAROSCOPY FOR GENERAL SURGERY
K950278 · Olympus America, Inc. · Feb 1995
KSEA STEINER ELECTROMECHANIC MORCELLATORT
K946213 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR
K946241 · Ethicon Endo-Surgery, Inc. · Jan 1995
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS
K946164 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K946023 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
K945751 · KARL STORZ Endoscopy-America, Inc. · Dec 1994