Cleared Traditional

K882269 - STORZ DIAGNOSTIC MICROSCOPE SYSTEM

K882269 is the FDA 510(k) clearance for STORZ DIAGNOSTIC MICROSCOPE SYSTEM by Storz Instrument Co.. It is a Class 1 General & Plastic Surgery device (product code EPT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K882269 · Storz Instrument Co. · General & Plastic Surgery device
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Jun 1988
Decision
23d
Days
Class 1
Risk

K882269 is an FDA 510(k) clearance for the STORZ DIAGNOSTIC MICROSCOPE SYSTEM. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - the FDA general and plastic surgery 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 K882269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date June 23, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPT Microscope, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EPT Microscope, Surgical

All 12
Devices cleared under the same product code (EPT) and FDA review panel - the closest regulatory comparables to K882269.
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
K942233 · Carl Zeiss, Inc. · Jul 1994
STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.
K903412 · Storz Instrument Co. · Sep 1990
OPMI CS
K883581 · Carl Zeiss, Inc. · Sep 1988
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811 · Carl Zeiss, Inc. · Apr 1986
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
K844858 · Storz Instrument Co. · Mar 1985
MICROSCOPE
K822561 · Treace Medical, Inc. · Sep 1982