Cleared Traditional

K952259 - STORZ MICROSEAL DP8030 & DP8045 PHACOEM...

K952259 is the FDA 510(k) clearance for STORZ MICROSEAL DP8030 & DP8045 PHACOEM... by Storz Instrument Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K952259 · Storz Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
30d
Days
Class 2
Risk

K952259 is an FDA 510(k) clearance for the STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES. 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 June 14, 1995 after a review of 30 days - a notably fast clearance cycle.

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: 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 Storz Instrument Co. devices

Submission Details

510(k) Number K952259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date June 14, 1995
Days to Decision 30 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
80d faster than avg
Panel avg: 110d · This submission: 30d
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 K952259.
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K952213 · Alcon Laboratories · Aug 1995
STORZ DP4101 BASIC I/A PACK
K953078 · Storz Instrument Co. · Aug 1995
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
K951824 · Nidek, Inc. · Jul 1995
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · Storz Instrument Co. · Jun 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · American Optical Corp. · May 1995
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · Storz Instrument Co. · Mar 1995