510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841981Substantially Equivalent

4Mm & 5Mm File

Stainless Mfg., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841981 is the FDA 510(k) clearance record for 4MM & 5MM FILE, a class I device, cleared for Stainless Mfg., Inc. on under FDA product code HTP (File). FDA records list 19 510(k) clearances for Stainless Mfg., Inc., from to . As of , FDA records show no recalls naming K841981.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HTP File
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Stainless Mfg., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HTP

Trailing 12 months

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

FDA records show no clearances under product code HTP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HTP, 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