Cleared Traditional

K953078 - STORZ DP4101 BASIC I/A PACK

K953078 is the FDA 510(k) clearance for STORZ DP4101 BASIC I/A PACK by Storz Instrument Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K953078 · Storz Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
35d
Days
Class 2
Risk

K953078 is an FDA 510(k) clearance for the STORZ DP4101 BASIC I/A PACK. 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 August 7, 1995 after a review of 35 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 K953078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date August 07, 1995
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
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
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