Cleared Traditional

K932668 - OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER

K932668 is an FDA 510(k) clearance for OPHTHALMIC SURGICAL PNEUMATIC SCISSORS ..., manufactured by Synergetics, Inc.. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K932668 · Synergetics, Inc. · Ophthalmic device
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Feb 1994
Decision
266d
Days
Class 2
Risk

K932668 is an FDA 510(k) clearance for the OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 266 days - an extended review 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: 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 Synergetics, Inc. devices

FDA 510(k) Submission Details - K932668

510(k) Number K932668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date February 23, 1994
Days to Decision 266 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 110d · This submission: 266d
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 90
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K932668.
PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
K940391 · Peregrine Surgical , Ltd. · Jun 1994
SUPRA-VIT(TM)
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STORZ FIBEROPTIC PICK MANIPULATOR
K933907 · Storz Instrument Co. · Mar 1994
INTERTIP INFUSION SET
K934204 · Oasis Medical, Inc. · Feb 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984 · Storz Instrument Co. · Jan 1994
BARE-FIBER ENDOILLUMINATOR
K933208 · Surgical Technologies, Inc. · Dec 1993