Cleared Traditional

K910973 - DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE

K910973 is the FDA 510(k) clearance for DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE by Surgical Technologies, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K910973 · Surgical Technologies, Inc. · Ophthalmic device
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Apr 1991
Decision
50d
Days
Class 2
Risk

K910973 is an FDA 510(k) clearance for the DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Surgical Technologies, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 26, 1991 after a review of 50 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 Surgical Technologies, Inc. devices

Submission Details

510(k) Number K910973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date April 26, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
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 47
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K910973.
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
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K912253 · Ocular Instruments, Inc. · Aug 1991
SITE DISPOSABLE CUTTER AND ACCESSORIES
K896943 · Site Microsurgical Systems, Inc. · Mar 1990
I/A HANDPIECE
K896754 · Advanced Surgical Products, Inc. · Jan 1990
MULTI-USE I/A HANDPIECE
K896305 · Advanced Surgical Products, Inc. · Dec 1989