Cleared Traditional

K862664 - JEDMED CCD CAMERA SYSTEM

K862664 is an FDA 510(k) clearance for JEDMED CCD CAMERA SYSTEM, manufactured by Jedmed Instrument Co.. The device is a Class 1 General & Plastic Surgery device with product code FWD cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K862664 · Jedmed Instrument Co. · General & Plastic Surgery device
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Jul 1986
Decision
16d
Days
Class 1
Risk

K862664 is an FDA 510(k) clearance for the JEDMED CCD CAMERA SYSTEM. Classified as Camera, Television, Microsurgical, Without Audio (product code FWD), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on July 30, 1986 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - 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 Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K862664

510(k) Number K862664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date July 30, 1986
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

FWD Device Classification - Class 1, General Controls

Product Code FWD Camera, Television, Microsurgical, Without Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
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 - FWD Camera, Television, Microsurgical, Without Audio

Devices cleared under the same product code (FWD) and FDA review panel - the closest regulatory comparables to K862664.
FDX SOLID STATE VIDEO CAMERA MODEL 5950
K891236 · Medical Dynamics, Inc. · Apr 1989
JEDMED MICRO CCD CAMERA SYSTEM
K882166 · Jedmed Instrument Co. · Jun 1988
JEDMED MINI-MOS VIDEO CAMERA
K862145 · Jedmed Instrument Co. · Jun 1986
JEDMED CCD-02 VIDEO CAMERA SYSTEM
K862034 · Jedmed Instrument Co. · Jun 1986