Cleared Traditional

K941286 - SUTURE MANIPULATOR

K941286 is an FDA 510(k) clearance for SUTURE MANIPULATOR, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K941286 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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May 1994
Decision
92d
Days
Class 2
Risk

K941286 is an FDA 510(k) clearance for the SUTURE MANIPULATOR. 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 20, 1994 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K941286

510(k) Number K941286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1994
Decision Date May 20, 1994
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1066
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K941286.
TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940347 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
LAPAROSCOPY DILATION SYSTEM
K942201 · Richard Wolf Medical Instruments Corp. · May 1994
SUCTION AND IRRIGATION TUBES
K942202 · Richard Wolf Medical Instruments Corp. · May 1994
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
K935786 · Cabot Medical Corp. · May 1994
LAPAROSCOPIC/SUCTION/IRRIGATION PROBE
K935826 · Core Dynamics, Inc. · May 1994
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
K940011 · Phx Technologies Corp. · May 1994