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) → FWF — Camera, Television, Endoscopic, Without Audio # FWF · Camera, Television, Endoscopic, Without Audio _General, Plastic Surgery · 21 CFR 878.4160 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF ## Overview - **Product Code:** FWF - **Device Name:** Camera, Television, Endoscopic, Without Audio - **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 (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K053412](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K053412.md) | FLEXISCOPE, MODELS 50MH AND 50 MHC | Schoelly Imaging, Inc. | Feb 23, 2006 | SESE | | [K990154](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K990154.md) | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | Karl Storz Imaging, Inc. | Jun 1, 1999 | SESE | | [K982754](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K982754.md) | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) | A.Stein - Regulatory Affairs Consulting | Jan 8, 1999 | SESE | | [K982965](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K982965.md) | ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | Nov 23, 1998 | SESE | | [K982397](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K982397.md) | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM | Angiolaz, Inc. | Sep 10, 1998 | SESE | | [K982409](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K982409.md) | VES 1501-M | Angiolaz, Inc. | Aug 21, 1998 | SESE | | [K981819](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K981819.md) | ANGIOLAZ VES-1CAM | Angiolaz, Inc. | Aug 4, 1998 | SESE | | [K944707](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K944707.md) | ISOLATED CAMERA HEAD | Envision Medical Corp. | Oct 7, 1994 | SESE | | [K930297](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K930297.md) | FUJINON VIDEO LAPAROSCOPE, MODIFIED | Fujinon, Inc. | Mar 29, 1994 | SESE | | [K934682](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K934682.md) | SURGICAL VIDEO CAMERA AND ACCESSORIES | Medical Dynamics, Inc. | Feb 15, 1994 | SESE | | [K932628](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K932628.md) | ENDOSCOPIC VIDEO CAMERA | Stephen Chakoff, Inc. | Oct 15, 1993 | SESE | | [K926166](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K926166.md) | COAST VIDEO ENDOSCOPIC IMAGING SYSTEM | Optik | Jun 1, 1993 | SESE | | [K930053](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K930053.md) | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | Medical Devices, Inc. | May 17, 1993 | SESE | | [K925108](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K925108.md) | INTEGRATED VISUALIZATION SYSTEM | Neuro Navigational Corp. | Jan 29, 1993 | SESE | | [K923160](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K923160.md) | 3DSCOPE | American Surgical Technologies Corp. | Dec 10, 1992 | SESE | | [K911163](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K911163.md) | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS | Imagyn Medical, Inc. | Jun 3, 1991 | SESE | | [K905393](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K905393.md) | HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR | Frigitronics, Inc. | Jan 16, 1991 | SESE | | [K881014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K881014.md) | THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM | KARL STORZ Endoscopy-America, Inc. | Apr 14, 1988 | SESE | | [K872661](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K872661.md) | RGB CAMERA SYSTEM | Aspen Laboratories, Inc. | Jul 21, 1987 | SESE | | [K871056](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K871056.md) | MEDICAM S-4 SURGICAL CAMERA | M.P. Video, Inc. | Mar 31, 1987 | SESE | ## Top Applicants - Angiolaz, Inc. — 3 clearances - Stephen Chakoff, Inc. — 1 clearance - Schoelly Imaging, Inc. — 1 clearance - Richard Wolf Medical Instruments Corp. — 1 clearance - Optik — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF) **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. 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