Cleared Traditional

K955901 - STORZ DP4310DELUXE PHACO PACK WITHOUT R...

K955901 is the FDA 510(k) clearance for STORZ DP4310DELUXE PHACO PACK WITHOUT R... by Storz Instrument Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955901 · Storz Instrument Co. · Ophthalmic device
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955901 is an FDA 510(k) clearance for the STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX. 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 March 28, 1996 after a review of 90 days - within the typical 510(k) review window.

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. 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 Storz Instrument Co. devices

Submission Details

510(k) Number K955901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1995
Decision Date March 28, 1996
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
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 K955901.
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K961820 · Storz Instrument Co. · Jul 1996
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
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SYNERGIST POWER PACK
K960414 · Chiron Vision Corp. · Apr 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · Alcon Laboratories · Mar 1996
STORZ I/A HANDPIECES
K951463 · Storz Instrument Co. · Oct 1995
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K944993 · Chiron Vision Corp. · Oct 1995