Cleared Traditional

K832887 - ELECTRONIC UNIT

K832887 is an FDA 510(k) clearance for ELECTRONIC UNIT, manufactured by Surgi-Quip Inc.U. The device is a Class 1 General & Plastic Surgery device with product code EPT cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K832887 · Surgi-Quip Inc.U · General & Plastic Surgery device
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Oct 1983
Decision
39d
Days
Class 1
Risk

K832887 is an FDA 510(k) clearance for the ELECTRONIC UNIT. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 39 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 Surgi-Quip Inc.U devices

FDA 510(k) Submission Details - K832887

510(k) Number K832887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date October 04, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

EPT Device Classification - Class 1, General Controls

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 14
Devices cleared under the same product code (EPT) and FDA review panel - the closest regulatory comparables to K832887.
STORZ DIAGNOSTIC MICROSCOPE SYSTEM
K882269 · Storz Instrument Co. · Jun 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
VC III
K823011 · Teknar, Inc. · Nov 1982
MICROSCOPE
K822561 · Treace Medical, Inc. · Sep 1982
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014 · Kelleher Corp. · Aug 1982