Cleared Traditional

K920582 - 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.

K920582 is an FDA 510(k) clearance for 180 TIP, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K920582

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
Combination Product No
PCCP Authorized No
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.

HQE Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K920582.
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K921758 · Storz Instrument Co. · Jul 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K921460 · Storz Instrument Co. · Jul 1992
DISPOSABLE POSTERIOR MICROSCISSORS
K920718 · Storz Instrument Co. · May 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · Storz Instrument Co. · Mar 1992
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384 · Nidek, Inc. · Dec 1991
KPE 220 TS, NONSTERILE
K914221 · Ipax, Inc. · Oct 1991