Product code FZZ
- Device name
- Marker, Skin
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4660
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042555 | SURGICHIP TAG SURGICAL MARKER | Surgichip, Inc. | 2004-11-09 |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | 1992-05-14 |
| K914759 | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | 1992-04-21 |
| K912730 | ROCKET SURGICAL SKIN MARKING PEN | West Texas Lighthouse For the Blind | 1991-11-07 |
| K905143 | SKIN MARKER | Aesculap, Inc. | 1991-02-06 |
| K904559 | QUALTEX SKIN MARKER | Qualtex, Inc. | 1990-12-13 |
| K896792 | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
| K864371 | SURGICAL SKIN MARKER | Myocure, Inc. | 1986-11-17 |
| K863280 | DERMAMARKER | Dermacare Products, Inc. | 1986-09-09 |
| K861772 | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | 1986-05-21 |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1985-01-14 |
| K843116 | DISPOSABLE SKIN MARKING PEN | E.M. Adams | 1984-08-17 |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | 1984-06-11 |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1984-04-25 |
| K840470 | SURGISCRIBE MARKING PEN | Surgicot, Inc. | 1984-03-12 |
| K831372 | TLS SURGICAL MARKER | Porex Medical | 1983-06-24 |
| K830298 | ACCU-LINE SURGICAL MARKER | Accu-Line | 1983-06-02 |
| K830703 | GLOMARK | Alphamedix, Inc. | 1983-04-28 |
| K821063 | SKIN MARKERS | Devon Industries, Inc. | 1982-06-25 |
| K790084 | SURGICAL RULER AND PEN | Devon Industries, Inc. | 1979-02-26 |
| K781694 | PEN, MARK-3 SKIN MARKING FOUNTAIN | Omega Mark-3 Pen Corp. | 1978-12-04 |
| K781770 | SKIN MARKING PEN | Abco Dealers, Inc. | 1978-11-15 |
| K761323 | SURGICAL MARKING PEN | Richard-Allan Medical Ind., Inc. | 1977-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841439115237 | Opti-Tatt | Qfix | 2026-05-29 |
| 00841439115244 | Opti-Tatt | Qfix | 2026-05-29 |
| 00841439115251 | Opti-Tatt | Qfix | 2026-05-29 |
| 10080196771844 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-01-12 |
| 07540277010041 | RMAC Surgical | RMAC Surgical, Inc | 2026-01-06 |
| 10198956206045 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-11-07 |
| 10080196771851 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-12 |
| 00754027700275 | RMAC Surgical | RMAC Surgical, Inc | 2025-06-03 |
| 10080196326006 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-06-02 |
| 10198459271694 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2025-02-23 |
| 10080196031436 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-07-29 |
| 10197106628232 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-05-07 |
| G141572182480 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2023-02-13 |
| G14157218000 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2023-02-13 |
| G141572182280 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2023-02-13 |
| 10193489482898 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10193489707243 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10080196515790 | Medline | MEDLINE INDUSTRIES, INC. | 2021-08-17 |
| 10195594147495 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-07-16 |
| 10195594165222 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-07-15 |
| 09349967004067 | Skin MarkOR Regular Tip | THE O R COMPANY PTY LTD | 2021-04-12 |
| 09349967004036 | Skin MarkOR Fine Tip | THE O R COMPANY PTY LTD | 2021-04-12 |
| 10195594962807 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2021-03-26 |
| G047SMSRKT1 | Surgi-Sign | Or-6, LLC | 2021-02-27 |
| G047SMSEYE1 | Surgi-Sign | Or-6, LLC | 2021-02-27 |
| G047SMSWAND1 | Surgi-Sign | Or-6, LLC | 2021-02-27 |
| G047SMS21 | Surgi-Sign | Or-6, LLC | 2021-02-27 |
| G047SMS11 | Surgi-Sign | Or-6, LLC | 2021-02-27 |
| 10381780212058 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10381780025320 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |