FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CONCEPT VIDEO IMAGING SYSTEM

K Number: K850749 · Decision May 20, 1985
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
17
Applicant Total
83
Review Days
84

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
CONCEPT VIDEO IMAGING SYSTEM
K Number
K850749
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4160
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Concept, Inc.
Date Received
February 25, 1985
Decision Date
May 20, 1985
Product Code
KQM
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KQM Camera, Surgical And Accessories

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KQM), ordered by most recent decision date.

View all

Other Clearances by Concept, Inc.

K Number Device Name
K912640 CONCEPT ENDOSTEAL FIXATION DEVICE
K912957 CONCEPT MICROMILL
K896648 CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
K894929 STAPLE FIXATION SYSTEM
K892376 INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
K891109 PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
K881954 CONCEPT POWER SYSTEM
K884255 CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K882121 C-FLO SUCTION TUBE
K880414 TENDON HARVESTER
Search all 83 clearances from Concept, Inc. →