FZZ — Marker, Skin Class I
FDA product code FZZ covers "Marker, Skin", a Class I medical device regulated under 21 CFR 878.4660. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FZZ
- Device Class
- Class I
- Regulation Number
- 878.4660
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042555 | surgichip | SURGICHIP TAG SURGICAL MARKER | November 9, 2004 |
| K915066 | american medical mfg | DISPOSABLE SKIN MARKER | May 14, 1992 |
| K914759 | freckles publications | BLOOM TRANSPARENT STENCIL | April 21, 1992 |
| K912730 | west texas lighthouse for the blind | ROCKET SURGICAL SKIN MARKING PEN | November 7, 1991 |
| K905143 | aesculap | SKIN MARKER | February 6, 1991 |
| K904559 | qualtex | QUALTEX SKIN MARKER | December 13, 1990 |
| K896792 | westmark, sterile packing systems, inc. (sps) | SURGICAL SKIN MARKER | December 27, 1989 |
| K864371 | myocure | SURGICAL SKIN MARKER | November 17, 1986 |
| K863280 | dermacare products | DERMAMARKER | September 9, 1986 |
| K861772 | pacific poly crafts | LASER SKIN MARKER AND MASK WHITE LOTION | May 21, 1986 |
| K844865 | precision dynamics | SECURLINE SURGICAL SKIN MARKER 1000 | January 14, 1985 |
| K843116 | e.m. adams | DISPOSABLE SKIN MARKING PEN | August 17, 1984 |
| K841085 | scanlan intl | SCANLAN COLORMARK SKIN MARKER | June 11, 1984 |
| K840820 | precision dynamics | SECURLINE SURGICAL SKIN MARKER 1000 | April 25, 1984 |
| K840470 | surgicot | SURGISCRIBE MARKING PEN | March 12, 1984 |
| K831372 | porex medical | TLS SURGICAL MARKER | June 24, 1983 |
| K830298 | accu-line | ACCU-LINE SURGICAL MARKER | June 2, 1983 |
| K830703 | alphamedix | GLOMARK | April 28, 1983 |
| K821063 | devon industries | SKIN MARKERS | June 25, 1982 |
| K790084 | devon industries | SURGICAL RULER AND PEN | February 26, 1979 |