510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800971Substantially Equivalent

M.r. Assoc. Magnetic Extractor

Mr Associates, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800971 is the FDA 510(k) clearance record for M.R. ASSOC. MAGNETIC EXTRACTOR, a class II device, cleared for Mr Associates, Inc. on under FDA product code FCC (Endoscopic Magnetic Retriever). FDA's definition for product code FCC reads: "to endoscopically retrieve magnetic foreign objects". FDA records list 15 510(k) clearances for Mr Associates, Inc. As of , FDA records show no recalls naming K800971.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FCC Endoscopic Magnetic Retriever
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mr Associates, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FCC

Trailing 12 months

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

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