Cleared Traditional

K920582 - 180 TIP

K920582 is the FDA 510(k) clearance for 180 TIP by Site Microsurgical Systems, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K920582 · Site Microsurgical Systems, Inc. · Ophthalmic device
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May 1992
Decision
88d
Days
Class 2
Risk

K920582 is an FDA 510(k) clearance for the 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on May 8, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 Site Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K920582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date May 08, 1992
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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.

Regulatory Peers - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 37
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K920582.
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