Cleared Traditional

K946227 - STORZ PREMIERE MICROSURGICAL SYSTEM

K946227 is the FDA 510(k) clearance for STORZ PREMIERE MICROSURGICAL SYSTEM 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.

K946227 · Storz Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
90d
Days
Class 2
Risk

K946227 is an FDA 510(k) clearance for the STORZ PREMIERE(R) MICROSURGICAL SYSTEM. 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 22, 1995 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 K946227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date March 22, 1995
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 K946227.
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
K952259 · Storz Instrument Co. · Jun 1995
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · Storz Instrument Co. · Jun 1995
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · American Optical Corp. · May 1995
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K944994 · Chiron Vision Corp. · Mar 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994