Cleared Traditional

K973943 - INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL H...

K973943 is the FDA 510(k) clearance for INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL H... 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 315-day FDA review.

K973943 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
315d
Days
Class 2
Risk

K973943 is an FDA 510(k) clearance for the INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS.... 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 27, 1998 after a review of 315 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 K973943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1997
Decision Date August 27, 1998
Days to Decision 315 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
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 K973943.
INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)
K980129 · Richard Wolf Medical Instruments Corp. · Nov 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · Aesculap, Inc. · Sep 1998
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
K981940 · Dexide, Inc. · Sep 1998
MULTAPORT CANNULA REDUCER AND ACCESSORIES
K981941 · Dexide, Inc. · Jul 1998
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
K973430 · Eastman Kodak Company · Jul 1998
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
K974771 · Stryker Endoscopy · May 1998