510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943968Substantially Equivalent

Tunneler

Denver Biomedicals, Inc., Evergreen CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943968 is the FDA 510(k) clearance record for TUNNELER, a class I device, cleared for Denver Biomedicals, Inc. on under FDA product code MDM (Instrument, Manual, Surgical, General Use). FDA records list 10 510(k) clearances for Denver Biomedicals, Inc., from to . As of , FDA records show no recalls naming K943968.

Clearance record

Decision date
Received
(198 days to decision)
Product code
MDM Instrument, Manual, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Denver Biomedicals, Inc. 6851 Hwy. 73, Evergreen CO
510(k) summary
Summary
Third party review
No

Clearances, product code MDM

Trailing 12 months

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

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