Cleared Traditional

K980129 - INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)

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

K980129 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K980129

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.

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 K980129.
FUJINON EVL-F VIDEO LAPROSCOPE
K983561 · Fujinon, Inc. · Dec 1998
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
K983279 · Richard Wolf Medical Instruments Corp. · Dec 1998
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
K983538 · Solos Endoscopy, Inc. · Nov 1998
MGB LAPALUX TELESCOPE
K982013 · Mgb Endoskopische Gerate GmbH · Oct 1998
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
K982417 · Innerdyne, Inc. · Oct 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · Aesculap, Inc. · Sep 1998