Product code FZZ— General, Plastic Surgery

FDA has cleared 23 devices under product code FZZ between 1977 and 2004, filed by 21 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20041 clearance
• 19922 clearances
• 19912 clearances
• 19901 clearance
• 19891 clearance
• 19863 clearances
• 19851 clearance
• 19844 clearances
• 19833 clearances
• 19821 clearance
• 19791 clearance
• 19782 clearances
• 19771 clearance

• Precision Dynamics Corp.2 clearances
• Devon Industries, Inc.2 clearances
• Westmark, Sterile Packing Systems, Inc. (Sps)1 clearance
• West Texas Lighthouse For the Blind1 clearance
• Surgicot, Inc.1 clearance
• Surgichip, Inc.1 clearance
• Scanlan Intl., Inc.1 clearance
• Richard-Allan Medical Ind., Inc.1 clearance
• Qualtex, Inc.1 clearance
• Porex Medical1 clearance

• K042555 — SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.·2004-11-09
• K915066 — DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.·1992-05-14
• K914759 — BLOOM TRANSPARENT STENCILFreckles Publications, Inc.·1992-04-21
• K912730 — ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the Blind·1991-11-07
• K905143 — SKIN MARKERAesculap, Inc.·1991-02-06
• K904559 — QUALTEX SKIN MARKERQualtex, Inc.·1990-12-13
• K896792 — SURGICAL SKIN MARKERWestmark, Sterile Packing Systems, Inc. (Sps)·1989-12-27
• K864371 — SURGICAL SKIN MARKERMyocure, Inc.·1986-11-17
• K863280 — DERMAMARKERDermacare Products, Inc.·1986-09-09
• K861772 — LASER SKIN MARKER AND MASK WHITE LOTIONPacific Poly Crafts·1986-05-21
• K844865 — SECURLINE SURGICAL SKIN MARKER 1000Precision Dynamics Corp.·1985-01-14
• K843116 — DISPOSABLE SKIN MARKING PENE.M. Adams·1984-08-17
• K841085 — SCANLAN COLORMARK SKIN MARKERScanlan Intl., Inc.·1984-06-11
• K840820 — SECURLINE SURGICAL SKIN MARKER 1000Precision Dynamics Corp.·1984-04-25
• K840470 — SURGISCRIBE MARKING PENSurgicot, Inc.·1984-03-12
• K831372 — TLS SURGICAL MARKERPorex Medical·1983-06-24
• K830298 — ACCU-LINE SURGICAL MARKERAccu-Line·1983-06-02
• K830703 — GLOMARKAlphamedix, Inc.·1983-04-28
• K821063 — SKIN MARKERSDevon Industries, Inc.·1982-06-25
• K790084 — SURGICAL RULER AND PENDevon Industries, Inc.·1979-02-26
• K781694 — PEN, MARK-3 SKIN MARKING FOUNTAINOmega Mark-3 Pen Corp.·1978-12-04
• K781770 — SKIN MARKING PENAbco Dealers, Inc.·1978-11-15
• K761323 — SURGICAL MARKING PENRichard-Allan Medical Ind., Inc.·1977-01-12