Cleared Traditional

K946136 - INFINITECH LIGHTED INFUSION CANNULA (FDA 510(k) Clearance)

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

K946136 · Surgical Technologies, Inc. · Ophthalmic device
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Oct 1995
Decision
290d
Days
Class 2
Risk

K946136 is an FDA 510(k) clearance for the INFINITECH LIGHTED INFUSION CANNULA. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Chesterfield, US). The FDA issued a Cleared decision on October 2, 1995 after a review of 290 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Technologies, Inc. devices

Submission Details

510(k) Number K946136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1994
Decision Date October 02, 1995
Days to Decision 290 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 110d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.