510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870349Substantially Equivalent

Biodynamics Femoral Canal Brush #1201

Biodynamic Technologies, Inc., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870349 is the FDA 510(k) clearance record for BIODYNAMICS FEMORAL CANAL BRUSH #1201, a class I device, cleared for Biodynamic Technologies, Inc. on under FDA product code HTR (Rasp). FDA records list 30 510(k) clearances for Biodynamic Technologies, Inc., from to . As of , FDA records show no recalls naming K870349.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HTR Rasp
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Biodynamic Technologies, Inc. 727 Twenty-Third St. S., Arlington VA
Third party review
No

Clearances, product code HTR

Trailing 12 months

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

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