Cleared Traditional

SCITECH BI-MANUAL ADAPTER CLIPS (K910088) - FDA 510(k) Clearance

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

K910088 · Scitech Industries Partnership · Ophthalmic device
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Apr 1991
Decision
89d
Days
Class 2
Risk

K910088 is an FDA 510(k) clearance for the SCITECH BI-MANUAL ADAPTER CLIPS. Classified as Apparatus, Cautery, Radiofrequency, Battery-powered (product code HQQ), Class II - Special Controls.

Submitted by Scitech Industries Partnership (Woodcliff Lake, US). The FDA issued a Cleared decision on April 8, 1991 after a review of 89 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 Scitech Industries Partnership devices

Submission Details

510(k) Number K910088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date April 08, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
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.