510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000366Substantially Equivalent

Fixation Stylets, Models 335-287 and 335-288

Accufix Research Institute, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000366 is the FDA 510(k) clearance record for FIXATION STYLETS, MODELS 335-287 AND 335-288, a class II device, cleared for Accufix Research Institute on under FDA product code DRB (Stylet, Catheter). FDA records list one 510(k) clearance for Accufix Research Institute. As of , FDA records show no recalls naming K000366.

Clearance record

Decision date
Received
(70 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Accufix Research Institute 12503 E. Euclid Dr. # 20, Englewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code DRB

Trailing 12 months

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

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