Marker, Skin
FDA product code FZZ · Class I (low risk) · 21 CFR 878.4660 · General, Plastic Surgery
23510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Devon Industries, Inc. 2
- Precision Dynamics Corp. 2
- E.M. Adams 1
- Surgichip, Inc. 1
- American Medical Mfg., Inc. 1
- Freckles Publications, Inc. 1
- West Texas Lighthouse For the Blind 1
- Aesculap, Inc. 1
- Qualtex, Inc. 1
- Westmark, Sterile Packing Systems, Inc. (Sps) 1
- Myocure, Inc. 1
- Dermacare Products, Inc. 1
- Pacific Poly Crafts 1
- Richard-Allan Medical Ind., Inc. 1
- Scanlan Intl., Inc. 1
- Surgicot, Inc. 1
- Porex Medical 1
- Accu-Line 1
- Alphamedix, Inc. 1
- Omega Mark-3 Pen Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042555 | Surgichip Tag Surgical MarkerFZZ · Traditional | Surgichip, Inc. | 11/09/2004SE |
| K915066 | Disposable Skin MarkerFZZ · Traditional | American Medical Mfg., Inc. | 05/14/1992SE |
| K914759 | Bloom Transparent StencilFZZ · Traditional | Freckles Publications, Inc. | 04/21/1992SE |
| K912730 | Rocket Surgical Skin Marking PenFZZ · Traditional | West Texas Lighthouse For the Blind | 11/07/1991SE |
| K905143 | Skin MarkerFZZ · Traditional | Aesculap, Inc. | 02/06/1991SE |
| K904559 | Qualtex Skin MarkerFZZ · Traditional | Qualtex, Inc. | 12/13/1990SE |
| K896792 | Surgical Skin MarkerFZZ · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 12/27/1989SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | Myocure, Inc. | 11/17/1986SE |
| K863280 | DermamarkerFZZ · Traditional | Dermacare Products, Inc. | 09/09/1986SE |
| K861772 | Laser Skin Marker and Mask White LotionFZZ · Traditional | Pacific Poly Crafts | 05/21/1986SE |
| K844865 | Securline Surgical Skin Marker 1000FZZ · Traditional | Precision Dynamics Corp. | 01/14/1985SE |
| K843116 | Disposable Skin Marking PenFZZ · Traditional | E.M. Adams | 08/17/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | Scanlan Intl., Inc. | 06/11/1984SE |
| K840820 | Securline Surgical Skin Marker 1000FZZ · Traditional | Precision Dynamics Corp. | 04/25/1984SE |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | Surgicot, Inc. | 03/12/1984SE |
| K831372 | TLS Surgical MarkerFZZ · Traditional | Porex Medical | 06/24/1983SE |
| K830298 | Accu-Line Surgical MarkerFZZ · Traditional | Accu-Line | 06/02/1983SE |
| K830703 | GlomarkFZZ · Traditional | Alphamedix, Inc. | 04/28/1983SE |
| K821063 | Skin MarkersFZZ · Traditional | Devon Industries, Inc. | 06/25/1982SE |
| K790084 | Surgical Ruler and PenFZZ · Traditional | Devon Industries, Inc. | 02/26/1979SE |
| K781694 | Pen, MARK-3 Skin Marking FountainFZZ · Traditional | Omega Mark-3 Pen Corp. | 12/04/1978SE |
| K781770 | Skin Marking PenFZZ · Traditional | Abco Dealers, Inc. | 11/15/1978SE |
| K761323 | Surgical Marking PenFZZ · Traditional | Richard-Allan Medical Ind., Inc. | 01/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1872-2013 Class II | Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part…PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers… | Precision Dynamics Corporation | 07/10/2013Terminated |
| Z-1025-2013 Class III | Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and…Dual Tip Marker has inconsistent ink flow on the black permanent ink side. | Viscot Medical LLC | 08/22/2012Terminated |