Skin Marker
FDA 510(k) K905143 · Aesculap, Inc.
510(k) numberK905143
Submission
- Device name
- Skin Marker
- Applicant
- Aesculap, Inc.
Burlingame, CA, US - Received
- November 15, 1990
- Decision date
- February 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZZ – Marker, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4660
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZZ
| 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 |
| 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 |
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| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
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| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Skin Marker cleared by the FDA?
Skin Marker (K905143) received a 510(k) decision of Substantially Equivalent on February 6, 1991, 83 days after the submission was received.
What is the product code of K905143?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.