510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MCZClass I

Suture Removal Kit

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

MCZ is the FDA product code for Suture Removal Kit, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "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...". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
MCZ
Device name
Suture Removal Kit
FDA 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.
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
16

Clearances, product code MCZ

By decision year
15 clearances under product code MCZ with a decision year between 1981 and 2005, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code MCZ by decision year
YearClearances
19811
19911
19924
19934
19942
19961
19971
20051

Applicants with the most clearances

Product code MCZ
Applicants holding the most 510(k) clearances under product code MCZ
ApplicantClearances
American Healthcare Supply Co., Inc.2
Trinity Laboratories, Inc.2
American Carolina Stamping1
Amsino International, Inc.1
Carapace, Inc.1
Clinical Resources, Inc.1
Continental Medical Laboratories, Inc.1
Customed, Inc1
E.M. Adams Co., Inc.1
Grand Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order