M.R. Assoc. Magnetic Extractor

FDA 510(k) K800971 · Mr Associates, Inc.

Substantially Equivalent

510(k) numberK800971

Submission

Device name
M.R. Assoc. Magnetic Extractor
Applicant
Mr Associates, Inc.
Mchenry, IL, US
Received
April 23, 1980
Decision date
May 8, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FCC – Endoscopic Magnetic Retriever
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

to endoscopically retrieve magnetic foreign objects

Other 510(k)s with product code FCC

510(k)DeviceApplicantDecision
K904668Ie Magnetic ExtractorFCC · Traditional Olympus Corp.03/21/1991SE
K843135Brimfield Cannulated Magnetic RetrieverFCC · Traditional Brimfield Scientific Instruments09/26/1984SE

More from Brimfield Scientific Instruments

510(k)DeviceDecision
K800976M.R. Assoc. W Type Grasping ForcepsOCZ · Traditional 05/08/1980SE
K800975M.R. Assoc. True-Feel HandleKNS · Traditional 05/08/1980SE
K800974M.R. Assoc. Power CordKNS · Traditional 05/08/1980SE
K800973M.R. Assoc. Hot Biopsy ForcepsKNS · Traditional 05/08/1980SE
K800972M.R. Assoc. Tripod Grasping ForcepsOCZ · Traditional 05/08/1980SE
K800970M.R. Assoc. Basket RetrieversOCZ · Traditional 05/08/1980SE
K800969M.R. Assoc. CannulasOCZ · Traditional 05/08/1980SE
K800968M.R. Assoc. Rat Tooth Grasp ForcepsOCZ · Traditional 05/08/1980SE
K800967M.R. Assoc. Alligator Graspong ForcepsOCZ · Traditional 05/08/1980SE
K800966M.R. Assoc. Cytology BrushesFDX · Traditional 05/08/1980SE

Questions and answers

When was M.R. Assoc. Magnetic Extractor cleared by the FDA?

M.R. Assoc. Magnetic Extractor (K800971) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 15 days after the submission was received.

What is the product code of K800971?

The FDA product code is FCC – Endoscopic Magnetic Retriever, a Class II (moderate risk) device regulated under 21 CFR 876.1500.