Cleared Traditional

K980050 - MENTOR SKIN PROTECTION PAD

K980050 is an FDA 510(k) clearance for MENTOR SKIN PROTECTION PAD, manufactured by Mentor Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K980050 · Mentor Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
52d
Days
Class 2
Risk

K980050 is an FDA 510(k) clearance for the MENTOR SKIN PROTECTION PAD. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mentor Corp. devices

FDA 510(k) Submission Details - K980050

510(k) Number K980050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date February 27, 1998
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 1095
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K980050.
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · Ethicon Endo-Surgery, Inc. · Mar 1998
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
K980123 · Louisville Laboratories, Inc. · Mar 1998
KSEA ENDOTIP SYSTEM
K973909 · KARL STORZ Endoscopy-America, Inc. · Feb 1998
HERMES OPERATING ROOM CONTROL CENTER
K973700 · Computer Motion, Inc. · Feb 1998
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974336 · J-Lloyd Medical, Inc. · Feb 1998
ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
K972298 · The Altomec Corp. · Jan 1998