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MCZ — Suture Removal Kit Class I

FDA Device Classification

Classification Details

Product Code
MCZ
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050656amsino internationalAMSINO SUTURE REMOVAL KITMay 2, 2005
K964827continental medical laboratoriesPROD. NO. 01-132 - SUTURE REMOVAL KITFebruary 14, 1997
K963714grand medical productsGRAND MEDICAL SUTURE REMOVAL KITNovember 27, 1996
K943046sterile conceptsSKIN STAPLE REMOVAL TRAYSJuly 29, 1994
K941465clinical resourcesSUTURE REMOVAL KITApril 22, 1994
K931597carapaceCARAPACE INCISION AND DRAINAGE TRAYSNovember 5, 1993
K925015customedSTERILE SUTURE REMOVAL KITJune 7, 1993
K924835american healthcare supply coVALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560March 23, 1993
K924834american healthcare supply coPREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)March 23, 1993
K922339transidyne generalSUTURE REMOVAL KITDecember 11, 1992
K915827american carolina stampingA.C.S. SUTURE REMOVAL KITDecember 8, 1992
K920283trinity laboratoriesDISPOSABLE SKIN STAPLE REMOVERMay 22, 1992
K920280trinity laboratoriesSUTURE REMOVAL KIT, STERILE, DISPOSABLEMay 11, 1992
K910361megadyne medical productsSUTURE REMOVAL KITMarch 27, 1991
K812132e.m. adamsSTERILE SUTURE REMOVAL KITDecember 1, 1981