Cleared Traditional

K935270 - MODULAR FORCEP AND SCISSOR SYSTEM

K935270 is the FDA 510(k) clearance for MODULAR FORCEP AND SCISSOR 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 297-day FDA review.

K935270 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Aug 1994
Decision
297d
Days
Class 2
Risk

K935270 is an FDA 510(k) clearance for the MODULAR FORCEP AND SCISSOR 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 August 26, 1994 after a review of 297 days - an extended review 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: 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

Submission Details

510(k) Number K935270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date August 26, 1994
Days to Decision 297 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
182d slower than avg
Panel avg: 115d · This submission: 297d
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 682
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K935270.
KARL STORZ THORACIC SURGERY INSTRUMENTS
K940427 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH
K934704 · United States Surgical, A Division of Tyco Healthc · Sep 1994
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE
K943970 · Cook Ob/Gyn · Sep 1994
CCD ENDOCAM OFFICE 5510
K942817 · Richard Wolf Medical Instruments Corp. · Aug 1994
ENDOPATH OPTICAL OBTURATOR AND SLEEVE
K941027 · Ethicon Endo-Surgery, Inc. · Aug 1994
SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM
K942740 · Sharplan Lasers, Inc. · Aug 1994