Camera, Surgical And Accessories
This device is a surgical camera and associated accessories used to capture photographic or video documentation of surgical procedures, supporting clinical record-keeping, education, and quality assurance. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KQM, regulated under 21 CFR 878.4160 within the General and Plastic Surgery specialty. No special flags apply.
Basic Information
- Product Code
- KQM
- Device Class
- FDA class 1
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900160 | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | Jan 24, 1990 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K890826 | SONY VIDEO GRAPHIC PRINTER UP-850 | Mar 14, 1989 | Substantially Equivalent | SONY CORP. OF AMERICA |
| K885042 | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | Dec 22, 1988 | Substantially Equivalent | SONY MEDICAL ELECTRONICS CO. |
| K882958 | SONY VIDEO PRINTERS, UP SERIES | Aug 04, 1988 | Substantially Equivalent | SONY MEDICAL ELECTRONICS CO. |
| K882924 | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | Jul 26, 1988 | Substantially Equivalent | M.P. VIDEO, INC. |
| K873419 | VIDEO PRINTER SYSTEM | Nov 02, 1987 | Substantially Equivalent | TECHNOLOGY FOR IMAGING, INC. |
| K871595 | SURGICAL CAMERA ACCESSORIES | May 07, 1987 | Substantially Equivalent | M.P. VIDEO, INC. |
| K863800 | ENDOSCOPIC VIDEO CAMERA | Oct 14, 1986 | Substantially Equivalent | TECHNOLOGY FOR IMAGING, INC. |
| K860904 | VIDEO PRINTER, MODEL 3200 | Mar 28, 1986 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K850749 | CONCEPT VIDEO IMAGING SYSTEM | May 20, 1985 | Substantially Equivalent | CONCEPT, INC. |
| K843806 | VIS-1000 VIDEO SYSTEM | Dec 12, 1984 | Substantially Equivalent | VISTEK CORP. |
| K843295 | MED. DYNAMICS HIGH RESOLUTION SOLID ST | Dec 12, 1984 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K843294 | MED. DYNAMICS SATICAN VIDEO CAMERA 5410 | Dec 12, 1984 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K832342 | ENDOSCOPIC CAMERA TV W/AUDIO | Sep 12, 1983 | Substantially Equivalent | KAMIYA TSUSAN KAISHA, LTD. |
| K820626 | OPTI-DISC | Apr 09, 1982 | Substantially Equivalent | VIDEO-MEDICAL DEVICES, LTD. |
| K812405 | STERILE TV CAMERA & CORD COVER | Oct 20, 1981 | Substantially Equivalent | HYDRO-MED PRODUCTS, INC. |
| K811717 | GATOR DRAPES | Jul 20, 1981 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K810512 | MEDISEAL CAMERA COVERS | Mar 13, 1981 | Substantially Equivalent | JANIN GROUP, INC. |
FEI Numbers
This FDA classification entry is associated with 190 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 190 registration numbers. Click on an entry to view related FDA registrations.