FXN · Tape, Camera, Surgical
General, Plastic Surgery · 21 CFR 878.4160 · Class 1
Overview
| Product Code | FXN |
|---|---|
| Device Name | Tape, Camera, Surgical |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131596 | WOUND MEASURING & MONITORING DEVICE | Woundvision, LLC | Dec 11, 2013 | SESE |
| K130165 | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 | Advanced Planimetric Services, LLC | Aug 30, 2013 | SESE |
| K070426 | SILHOUETTE, MODEL 1000.01 | Aranz Medical Limited | Jun 29, 2007 | SESE |
| K962148 | VERGE VIDEOMETER | Verg, Inc. | Dec 20, 1996 | SESE |
Top Applicants
- Advanced Planimetric Services, LLC — 1 clearance
- Aranz Medical Limited — 1 clearance
- Verg, Inc. — 1 clearance
- Woundvision, LLC — 1 clearance
