FZZ · Marker, Skin
General, Plastic Surgery · 21 CFR 878.4660 · Class 1
Overview
| Product Code | FZZ |
|---|---|
| Device Name | Marker, Skin |
| Regulation | 21 CFR 878.4660 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042555 | SURGICHIP TAG SURGICAL MARKER | Surgichip, Inc. | Nov 9, 2004 | SESE |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | May 14, 1992 | SESE |
| K914759 | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | Apr 21, 1992 | SESE |
| K912730 | ROCKET SURGICAL SKIN MARKING PEN | West Texas Lighthouse For the Blind | Nov 7, 1991 | SESE |
| K905143 | SKIN MARKER | Aesculap, Inc. | Feb 6, 1991 | SESE |
| K904559 | QUALTEX SKIN MARKER | Qualtex, Inc. | Dec 13, 1990 | SESE |
| K896792 | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | Dec 27, 1989 | SESE |
| K864371 | SURGICAL SKIN MARKER | Myocure, Inc. | Nov 17, 1986 | SESE |
| K863280 | DERMAMARKER | Dermacare Products, Inc. | Sep 9, 1986 | SESE |
| K861772 | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | May 21, 1986 | SESE |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | Jan 14, 1985 | SESE |
| K843116 | DISPOSABLE SKIN MARKING PEN | E.M. Adams | Aug 17, 1984 | SESE |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | Jun 11, 1984 | SESE |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | Apr 25, 1984 | SESE |
| K840470 | SURGISCRIBE MARKING PEN | Surgicot, Inc. | Mar 12, 1984 | SESE |
| K831372 | TLS SURGICAL MARKER | Porex Medical | Jun 24, 1983 | SESE |
| K830298 | ACCU-LINE SURGICAL MARKER | Accu-Line | Jun 2, 1983 | SESE |
| K830703 | GLOMARK | Alphamedix, Inc. | Apr 28, 1983 | SESE |
| K821063 | SKIN MARKERS | Devon Industries, Inc. | Jun 25, 1982 | SESE |
| K790084 | SURGICAL RULER AND PEN | Devon Industries, Inc. | Feb 26, 1979 | SESE |
Top Applicants
- Devon Industries, Inc. — 2 clearances
- Precision Dynamics Corp. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Accu-Line — 1 clearance
- Aesculap, Inc. — 1 clearance
