Product Code: FZZ FDA class 1 21 CFR 878.4660

Marker, Skin

General, Plastic Surgery

The Marker, Skin (product code FZZ) is a surgical marking device used to draw or inscribe lines on the skin surface prior to incision, indicating planned surgical sites or anatomical landmarks in general and plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4660 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

183

Registration Numbers

184

Unique Applicants

Years Active

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Basic Information

Product Code: FZZ
Device Class: FDA class 1
Regulation Number: 878.4660
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K042555	SURGICHIP TAG SURGICAL MARKER	Nov 09, 2004	Substantially Equivalent	Surgichip, Inc.
K915066	DISPOSABLE SKIN MARKER	May 14, 1992	Substantially Equivalent	American Medical Mfg., Inc.
K914759	BLOOM TRANSPARENT STENCIL	Apr 21, 1992	Substantially Equivalent	Freckles Publications, Inc.
K912730	ROCKET SURGICAL SKIN MARKING PEN	Nov 07, 1991	Substantially Equivalent	West Texas Lighthouse For the Blind
K905143	SKIN MARKER	Feb 06, 1991	Substantially Equivalent	Aesculap, Inc.
K904559	QUALTEX SKIN MARKER	Dec 13, 1990	Substantially Equivalent	Qualtex, Inc.
K896792	SURGICAL SKIN MARKER	Dec 27, 1989	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K864371	SURGICAL SKIN MARKER	Nov 17, 1986	Substantially Equivalent	Myocure, Inc.
K863280	DERMAMARKER	Sep 09, 1986	Substantially Equivalent	Dermacare Products, Inc.
K861772	LASER SKIN MARKER AND MASK WHITE LOTION	May 21, 1986	Substantially Equivalent	Pacific Poly Crafts
K844865	SECURLINE SURGICAL SKIN MARKER 1000	Jan 14, 1985	Substantially Equivalent	Precision Dynamics Corp.
K843116	DISPOSABLE SKIN MARKING PEN	Aug 17, 1984	Substantially Equivalent	E.M. Adams
K841085	SCANLAN COLORMARK SKIN MARKER	Jun 11, 1984	Substantially Equivalent	Scanlan Intl., Inc.
K840820	SECURLINE SURGICAL SKIN MARKER 1000	Apr 25, 1984	Substantially Equivalent	Precision Dynamics Corp.
K840470	SURGISCRIBE MARKING PEN	Mar 12, 1984	Substantially Equivalent	Surgicot, Inc.
K831372	TLS SURGICAL MARKER	Jun 24, 1983	Substantially Equivalent	Porex Medical
K830298	ACCU-LINE SURGICAL MARKER	Jun 02, 1983	Substantially Equivalent	Accu-Line
K830703	GLOMARK	Apr 28, 1983	Substantially Equivalent	Alphamedix, Inc.
K821063	SKIN MARKERS	Jun 25, 1982	Substantially Equivalent	Devon Industries, Inc.
K790084	SURGICAL RULER AND PEN	Feb 26, 1979	Substantially Equivalent	Devon Industries, Inc.
K781694	PEN, MARK-3 SKIN MARKING FOUNTAIN	Dec 04, 1978	Substantially Equivalent	Omega Mark-3 Pen Corp.
K781770	SKIN MARKING PEN	Nov 15, 1978	Substantially Equivalent	Abco Dealers, Inc.
K761323	SURGICAL MARKING PEN	Jan 12, 1977	Substantially Equivalent	Richard-Allan Medical Ind., Inc.