510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935225Substantially Equivalent

Mitek Modular Drill Bit

Mitek Surgical Products, Inc., Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935225 is the FDA 510(k) clearance record for MITEK MODULAR DRILL BIT, a class I device, cleared for Mitek Surgical Products, Inc. on under FDA product code GFG (Bit, Surgical). FDA records list 31 510(k) clearances for Mitek Surgical Products, Inc., from to . As of , FDA records show no recalls naming K935225.

Clearance record

Decision date
Received
(157 days to decision)
Product code
GFG Bit, Surgical
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Mitek Surgical Products, Inc. 57 Providence Hwy., Norwood MA
510(k) summary
Statement
Third party review
No

Clearances, product code GFG

Trailing 12 months

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

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