Surgical Skin Marker
FDA 510(k) K896792 · Westmark, Sterile Packing Systems, Inc. (Sps)
510(k) numberK896792
Submission
- Device name
- Surgical Skin Marker
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US - Received
- December 1, 1989
- Decision date
- December 27, 1989
- 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 |
| K905143 | Skin MarkerFZZ · Traditional | Aesculap, Inc. | 02/06/1991SE |
| K904559 | Qualtex Skin MarkerFZZ · Traditional | Qualtex, Inc. | 12/13/1990SE |
| 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 |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K896800 | Irrigation TrayKYZ · Traditional | 05/24/1990SESK |
| K896799 | Paracervical/Pudendal TraysCAZ · Traditional | 04/23/1990SE |
| K896559 | Infant Feeding TubeFPD · Traditional | 03/13/1990SE |
| K896794 | Specimen ContainerLIO · Traditional | 03/01/1990SE |
| K896806 | Catheter Plug/ProtectorKNY · Traditional | 02/26/1990SE |
| K896798 | Tracheostomy TrayBTO · Traditional | 02/22/1990SE |
| K896797 | Suction Catheter KitBSY · Traditional | 02/16/1990SE |
| K896215 | Mercy Hip/Knee PackKKX · Traditional | 02/13/1990SE |
| K896804 | ManifoldGCX · Traditional | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | 02/06/1990SE |
Questions and answers
When was Surgical Skin Marker cleared by the FDA?
Surgical Skin Marker (K896792) received a 510(k) decision of Substantially Equivalent on December 27, 1989, 26 days after the submission was received.
What is the product code of K896792?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.