510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162046Substantially Equivalent

MINNE TIES MMF Suture System

Summit Medical, LLC, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162046 is the FDA 510(k) clearance record for MINNE TIES MMF Suture System, a class II device, cleared for Summit Medical, Inc. on under FDA product code DYX (Lock, Wire, And Ligature, Intraoral). FDA records list 27 510(k) clearances for Summit Medical, Inc., from to . As of , FDA records show no recalls naming K162046.

Clearance record

Decision date
Received
(260 days to decision)
Product code
DYX Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Applicant
Summit Medical, Inc. 815 Northwest Pkwy., Suite 100, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYX

Trailing 12 months

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

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