Tape, Camera, Surgical
A surgical camera tape is a recording medium or storage accessory used in conjunction with surgical camera systems to store audiovisual documentation of operative procedures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXN, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FXN
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131596 | WOUND MEASURING & MONITORING DEVICE | Dec 11, 2013 | Substantially Equivalent | Woundvision, LLC |
| K130165 | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 | Aug 30, 2013 | Substantially Equivalent | Advanced Planimetric Services, LLC |
| K070426 | SILHOUETTE, MODEL 1000.01 | Jun 29, 2007 | Substantially Equivalent | Aranz Medical Limited |
| K962148 | VERGE VIDEOMETER | Dec 20, 1996 | Substantially Equivalent | Verg, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.