510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925015Unknown

Sterile Suture Removal Kit

Customed, Inc, Fajardo PR / Traditional, Unknown
FDA source (opens on fda.gov)

K925015 is the FDA 510(k) clearance record for STERILE SUTURE REMOVAL KIT, a class I device, cleared for Customed, Inc. on under FDA product code MCZ (Suture Removal Kit). FDA's definition for product code MCZ reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at...". FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show 2 recalls naming K925015.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MCZ Suture Removal Kit
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Customed, Inc. Calle Igualdad #7, Fajardo PR
510(k) summary
Statement
Third party review
No

Clearances, product code MCZ

Trailing 12 months

FDA records hold no clearances under product code MCZ in the trailing twelve months.

FDA records show no clearances under product code MCZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MCZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260