510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K812132Substantially Equivalent

Sterile Suture Removal Kit

E.M. Adams Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812132 is the FDA 510(k) clearance record for STERILE SUTURE REMOVAL KIT, a class I device, cleared for E.M. Adams 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 23 510(k) clearances for E.M. Adams, from to . As of , FDA records show no recalls naming K812132.

Clearance record

Decision date
Received
(126 days to decision)
Product code
MCZ Suture Removal Kit
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
E.M. Adams 803 N. Front St. Suite 3, Mchenry IL
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