Madayag Type Needle

FDA 510(k) K813462 · Ocean Medical Products, Ltd.

Substantially Equivalent

510(k) numberK813462

Submission

Device name
Madayag Type Needle
Applicant
Ocean Medical Products, Ltd.
Mchenry, IL, US
Received
December 11, 1981
Decision date
March 1, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNW – Instrument, Biopsy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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More from Forcyte Medical, LLC

510(k)DeviceDecision
K882013Soft Tissue Biopsy DeviceDWO · Traditional 06/15/1988SE
K870896Notch-Needle, Wescott StyleGAA · Traditional 03/18/1987SE
K843719Single Wall Introducer NeedleDYB · Traditional 10/18/1984SE
K823693Myelography NeedleFMI · Traditional 02/07/1983SE
K823692Spinal NeedleBSP · Traditional 01/07/1983SE
K813460Chiba Skinny NeedleGAA · Traditional 01/07/1982SE
K813448Potts-Cournand Style NeedleGAA · Traditional 01/07/1982SE
K813461Percutaneous Entry Needle, SeldingerDRE · Traditional 12/29/1981SE

Questions and answers

When was Madayag Type Needle cleared by the FDA?

Madayag Type Needle (K813462) received a 510(k) decision of Substantially Equivalent on March 1, 1982, 80 days after the submission was received.

What is the product code of K813462?

The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.