Cleared Traditional

MENTOR WET-FIELD*II COAGULATOR (K881001) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881001 · Mentor O & O, Inc. · Ophthalmic device
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May 1988
Decision
65d
Days
Class 2
Risk

K881001 is an FDA 510(k) clearance for the MENTOR WET-FIELD*II COAGULATOR. Classified as Apparatus, Cautery, Radiofrequency, Battery-powered (product code HQQ), Class II - Special Controls.

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - the FDA ophthalmic 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

Submission Details

510(k) Number K881001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1988
Decision Date May 13, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQQ Apparatus, Cautery, Radiofrequency, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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 Ophthalmic devices follow this clearance model.