Cleared Traditional

K935926 - STORZ PHACO AND FRAG HANDPIECES

K935926 is the FDA 510(k) clearance for STORZ PHACO AND FRAG HANDPIECES by Storz Instrument Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K935926 · Storz Instrument Co. · Ophthalmic device
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Nov 1994
Decision
350d
Days
Class 2
Risk

K935926 is an FDA 510(k) clearance for the STORZ PHACO AND FRAG HANDPIECES. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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. Elevated predicate reliance profile. 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 Storz Instrument Co. devices

Submission Details

510(k) Number K935926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date November 28, 1994
Days to Decision 350 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
240d slower than avg
Panel avg: 110d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 112
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K935926.
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · Storz Instrument Co. · Mar 1995
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STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
MODIFIED SITE TXR SYSTEMS
K925828 · Site Microsurgical Systems, Inc. · Feb 1994