Cleared Traditional

K911160 - MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305

K911160 is an FDA 510(k) clearance for MENTOR WET-FIELD II AC COAGULATOR, manufactured by Mentor O & O, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K911160 · Mentor O & O, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1991
Decision
48d
Days
Class 2
Risk

K911160 is an FDA 510(k) clearance for the MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on May 2, 1991 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 O & O, Inc. devices

FDA 510(k) Submission Details - K911160

510(k) Number K911160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date May 02, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1790
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K911160.
ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS
K911365 · Northgate Technologies, Inc. · Jun 1991
ENDOPATH SURGICAL INSTRUMENTS
K910831 · Symbiosis Corp. · May 1991
BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR
K910663 · Mdt Corp., Inc. · May 1991
INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA
K911316 · Northgate Technologies, Inc. · Apr 1991
DISPOSABLE ELECTROSURGICAL BLADE
K910779 · Conmedcorp · Apr 1991
VALLEY FORGE BIPOLAR PEN OR FORCEPS
K910510 · Valley Forge Scientific Corp. · Apr 1991