Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160) → KQM — Camera, Surgical And Accessories # KQM · Camera, Surgical And Accessories _General, Plastic Surgery · 21 CFR 878.4160 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM ## Overview - **Product Code:** KQM - **Device Name:** Camera, Surgical And Accessories - **Regulation:** [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K900160.md) | ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER | Jedmed Instrument Co. | Jan 24, 1990 | SESE | | [K890826](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K890826.md) | SONY VIDEO GRAPHIC PRINTER UP-850 | Sony Corp. of America | Mar 14, 1989 | SESE | | [K885042](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K885042.md) | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | Sony Medical Electronics Co. | Dec 22, 1988 | SESE | | [K882958](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K882958.md) | SONY VIDEO PRINTERS, UP SERIES | Sony Medical Electronics Co. | Aug 4, 1988 | SESE | | [K882924](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K882924.md) | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | M.P. Video, Inc. | Jul 26, 1988 | SESE | | [K873419](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K873419.md) | VIDEO PRINTER SYSTEM | Technology For Imaging, Inc. | Nov 2, 1987 | SESE | | [K871595](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K871595.md) | SURGICAL CAMERA ACCESSORIES | M.P. Video, Inc. | May 7, 1987 | SESE | | [K863800](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K863800.md) | ENDOSCOPIC VIDEO CAMERA | Technology For Imaging, Inc. | Oct 14, 1986 | SESE | | [K860904](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K860904.md) | VIDEO PRINTER, MODEL 3200 | Medline Industries, Inc. | Mar 28, 1986 | SESE | | [K850749](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K850749.md) | CONCEPT VIDEO IMAGING SYSTEM | Concept, Inc. | May 20, 1985 | SESE | | [K843806](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K843806.md) | VIS-1000 VIDEO SYSTEM | Vistek Corp. | Dec 12, 1984 | SESE | | [K843295](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K843295.md) | MED. DYNAMICS HIGH RESOLUTION SOLID ST | Medline Industries, Inc. | Dec 12, 1984 | SESE | | [K843294](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K843294.md) | MED. DYNAMICS SATICAN VIDEO CAMERA 5410 | Medline Industries, Inc. | Dec 12, 1984 | SESE | | [K832342](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K832342.md) | ENDOSCOPIC CAMERA TV W/AUDIO | Kamiya Tsusan Kaisha, Ltd. | Sep 12, 1983 | SESE | | [K820626](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K820626.md) | OPTI-DISC | Video-Medical Devices, Ltd. | Apr 9, 1982 | SESE | | [K812405](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K812405.md) | STERILE TV CAMERA & CORD COVER | Hydro-Med Products, Inc. | Oct 20, 1981 | SESE | | [K811717](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K811717.md) | GATOR DRAPES | The Anspach Effort, Inc. | Jul 20, 1981 | SESE | | [K810512](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM/K810512.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KQM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com