Cleared Traditional

K980129 - INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURG...

K980129 is the FDA 510(k) clearance for INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURG... 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 295-day FDA review.

K980129 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Nov 1998
Decision
295d
Days
Class 2
Risk

K980129 is an FDA 510(k) clearance for the INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS). 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 November 5, 1998 after a review of 295 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 K980129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1998
Decision Date November 05, 1998
Days to Decision 295 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
180d slower than avg
Panel avg: 115d · This submission: 295d
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 K980129.
DCI ENDOSCOPE
K983363 · KARL STORZ Endoscopy-America, Inc. · Dec 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · United States Surgical, A Division of Tyco Healthc · Dec 1998
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
K983279 · Richard Wolf Medical Instruments Corp. · Dec 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · Aesculap, Inc. · Sep 1998
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
K981940 · Dexide, Inc. · Sep 1998
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER
K973943 · Richard Wolf Medical Instruments Corp. · Aug 1998