Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4660](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4660) → FZZ — Marker, Skin # FZZ · Marker, Skin _General, Plastic Surgery · 21 CFR 878.4660 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ ## Overview - **Product Code:** FZZ - **Device Name:** Marker, Skin - **Regulation:** [21 CFR 878.4660](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4660) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K042555.md) | SURGICHIP TAG SURGICAL MARKER | Surgichip, Inc. | Nov 9, 2004 | SESE | | [K915066](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K915066.md) | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | May 14, 1992 | SESE | | [K914759](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K914759.md) | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | Apr 21, 1992 | SESE | | [K912730](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K912730.md) | ROCKET SURGICAL SKIN MARKING PEN | West Texas Lighthouse For the Blind | Nov 7, 1991 | SESE | | [K905143](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K905143.md) | SKIN MARKER | Aesculap, Inc. | Feb 6, 1991 | SESE | | [K904559](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K904559.md) | QUALTEX SKIN MARKER | Qualtex, Inc. | Dec 13, 1990 | SESE | | [K896792](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K896792.md) | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | Dec 27, 1989 | SESE | | [K864371](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K864371.md) | SURGICAL SKIN MARKER | Myocure, Inc. | Nov 17, 1986 | SESE | | [K863280](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K863280.md) | DERMAMARKER | Dermacare Products, Inc. | Sep 9, 1986 | SESE | | [K861772](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K861772.md) | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | May 21, 1986 | SESE | | [K844865](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K844865.md) | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | Jan 14, 1985 | SESE | | [K843116](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K843116.md) | DISPOSABLE SKIN MARKING PEN | E.M. Adams | Aug 17, 1984 | SESE | | [K841085](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K841085.md) | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | Jun 11, 1984 | SESE | | [K840820](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K840820.md) | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | Apr 25, 1984 | SESE | | [K840470](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K840470.md) | SURGISCRIBE MARKING PEN | Surgicot, Inc. | Mar 12, 1984 | SESE | | [K831372](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K831372.md) | TLS SURGICAL MARKER | Porex Medical | Jun 24, 1983 | SESE | | [K830298](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K830298.md) | ACCU-LINE SURGICAL MARKER | Accu-Line | Jun 2, 1983 | SESE | | [K830703](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K830703.md) | GLOMARK | Alphamedix, Inc. | Apr 28, 1983 | SESE | | [K821063](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K821063.md) | SKIN MARKERS | Devon Industries, Inc. | Jun 25, 1982 | SESE | | [K790084](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K790084.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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