PDW · Internal Tissue Marker
General, Plastic Surgery · 21 CFR 878.4670 · Class 2
Overview
| Product Code | PDW |
|---|---|
| Device Name | Internal Tissue Marker |
| Regulation | 21 CFR 878.4670 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the Internal Tissue Marker is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated. (3) Performance data must demonstrate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life. (5) Labeling must include: (i) A warning that the device must not be used on a non-sterile surface prior to use internally. (ii) An expiration date/shelf life. (iii) Single use only labeling must be labeled directly on the device.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | Jul 29, 2016 | SESE |
| DEN130004 | MOERAE SURGICAL MARKING PEN | Moerae Matrix, Inc. | Dec 18, 2014 | DENG |
| K141318 | CIANNA MEDICAL SGS SYSTEM | Cianna Medical, Inc. | Aug 27, 2014 | SESE |
Top Applicants
- Cianna Medical, Inc. — 2 clearances
- Moerae Matrix, Inc. — 1 clearance
