510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830471Substantially Equivalent

Kelly-Wick Tanneler

Intl. Medical Prosthetics Research, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830471 is the FDA 510(k) clearance record for KELLY-WICK TANNELER, a class I device, cleared for Intl. Medical Prosthetics Research on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list one 510(k) clearance for Intl. Medical Prosthetics Research. As of , FDA records show no recalls naming K830471.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Intl. Medical Prosthetics Research 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DWS

Trailing 12 months

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

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