Skin Marker
510(k) K905143
Skin Marker is a medical device (FDA Class I; FDA product code FZZ, Marker, Skin) made by Aesculap, Inc., cleared under FDA 510(k) K905143 on 6 Feb 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905143 | Date6 Feb 1991 | StatusActive |
Official records
- FDA 510(k) database K905143
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FZZ
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4660
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code FZZ (Marker, Skin).
- SURGICAL SKIN MARKER by Westmark, Sterile Packing Systems, Inc. (Sps)
- 10405 Permanent Marker; Round Pen Regular Tip (Purple) by XODUS MEDICAL, INC.
- 10726 Correct Site Marker; Round Regular Tip; w/ Ruler by XODUS MEDICAL, INC.
- SECURLINE SURGICAL SKIN MARKER 1000 by PRECISION DYNAMICS CORPORATION
- SKIN MARKERS by Devon Industries, Inc.
- PEN, MARK-3 SKIN MARKING FOUNTAIN by Omega Mark-3 Pen Corp.
- SURGICHIP TAG SURGICAL MARKER by Surgichip, Inc.
- SCANLAN COLORMARK SKIN MARKER by Scanlan Intl., Inc.
- LASER SKIN MARKER AND MASK WHITE LOTION by Pacific Poly Crafts
- QUALTEX SKIN MARKER by Qualtex, Inc.