KQM · Camera, Surgical And Accessories
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | KQM |
|---|---|
| Device Name | Camera, Surgical And Accessories |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900160 | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | Jedmed Instrument Co. | Jan 24, 1990 | SESE |
| K890826 | SONY VIDEO GRAPHIC PRINTER UP-850 | Sony Corp. of America | Mar 14, 1989 | SESE |
| K885042 | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | Sony Medical Electronics Co. | Dec 22, 1988 | SESE |
| K882958 | SONY VIDEO PRINTERS, UP SERIES | Sony Medical Electronics Co. | Aug 4, 1988 | SESE |
| K882924 | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | M.P. Video, Inc. | Jul 26, 1988 | SESE |
| K873419 | VIDEO PRINTER SYSTEM | Technology For Imaging, Inc. | Nov 2, 1987 | SESE |
| K871595 | SURGICAL CAMERA ACCESSORIES | M.P. Video, Inc. | May 7, 1987 | SESE |
| K863800 | ENDOSCOPIC VIDEO CAMERA | Technology For Imaging, Inc. | Oct 14, 1986 | SESE |
| K860904 | VIDEO PRINTER, MODEL 3200 | Medline Industries, Inc. | Mar 28, 1986 | SESE |
| K850749 | CONCEPT VIDEO IMAGING SYSTEM | Concept, Inc. | May 20, 1985 | SESE |
| K843806 | VIS-1000 VIDEO SYSTEM | Vistek Corp. | Dec 12, 1984 | SESE |
| K843295 | MED. DYNAMICS HIGH RESOLUTION SOLID ST | Medline Industries, Inc. | Dec 12, 1984 | SESE |
| K843294 | MED. DYNAMICS SATICAN VIDEO CAMERA 5410 | Medline Industries, Inc. | Dec 12, 1984 | SESE |
| K832342 | ENDOSCOPIC CAMERA TV W/AUDIO | Kamiya Tsusan Kaisha, Ltd. | Sep 12, 1983 | SESE |
| K820626 | OPTI-DISC | Video-Medical Devices, Ltd. | Apr 9, 1982 | SESE |
| K812405 | STERILE TV CAMERA & CORD COVER | Hydro-Med Products, Inc. | Oct 20, 1981 | SESE |
| K811717 | GATOR DRAPES | The Anspach Effort, Inc. | Jul 20, 1981 | SESE |
| K810512 | MEDISEAL CAMERA COVERS | Janin Group, Inc. | Mar 13, 1981 | SESE |
Top Applicants
- Medline Industries, Inc. — 3 clearances
- M.P. Video, Inc. — 2 clearances
- Sony Medical Electronics Co. — 2 clearances
- Technology For Imaging, Inc. — 2 clearances
- Concept, Inc. — 1 clearance
