Cleared Traditional

K944707 - ISOLATED CAMERA HEAD

K944707 is an FDA 510(k) clearance for ISOLATED CAMERA HEAD, manufactured by Envision Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code FWF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K944707 · Envision Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
14d
Days
Class 1
Risk

K944707 is an FDA 510(k) clearance for the ISOLATED CAMERA HEAD. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by Envision Medical Corp. (Santa Barbara, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 14 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 Envision Medical Corp. devices

FDA 510(k) Submission Details - K944707

510(k) Number K944707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date October 07, 1994
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

FWF Device Classification - Class 1, General Controls

Product Code FWF Camera, Television, Endoscopic, 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 - FWF Camera, Television, Endoscopic, Without Audio

All 7
Devices cleared under the same product code (FWF) and FDA review panel - the closest regulatory comparables to K944707.
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
K982965 · Richard Wolf Medical Instruments Corp. · Nov 1998
FUJINON VIDEO LAPAROSCOPE, MODIFIED
K930297 · Fujinon, Inc. · Mar 1994
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K930053 · Medical Devices, Inc. · May 1993
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
K881014 · KARL STORZ Endoscopy-America, Inc. · Apr 1988
RGB CAMERA SYSTEM
K872661 · Aspen Laboratories, Inc. · Jul 1987
VIDEO CAMERA SYSTEM
K863598 · American Edwards Laboratories · Oct 1986