Manan Greene Needle

FDA 510(k) K851835 · Manan Manufacturing Co., Inc.

Substantially Equivalent

510(k) numberK851835

Submission

Device name
Manan Greene Needle
Applicant
Manan Manufacturing Co., Inc.
Skokie, IL, US
Received
April 28, 1985
Decision date
May 17, 1985
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
K873208Manan Turner Style NeedleKNW · Traditional 08/25/1987SE
K864405Manan Contrast Media Administration SetFPA · Traditional 12/18/1986SE
K863848Manan Brest Tumor Localization NeedleGAA · Traditional 10/14/1986SE
K852501Myelogram Procedure Tray · Traditional 07/11/1985SESD
K852018Arthrogram Tray for Double & Single Contrast Arthr · Traditional 07/11/1985SESD
K851834Manan Gwi Guide Wire IntroducerDWS · Traditional 07/11/1985SE
K851833Manan Seldinger NeedleDWS · Traditional 07/11/1985SE
K851832Naman Potts Cournand NeedleDWS · Traditional 07/11/1985SE
K852428Manan Epidural NeedleGCB · Traditional 06/27/1985SE
K852427Manan Spinal NeedleGAA · Traditional 06/27/1985SE

Questions and answers

When was Manan Greene Needle cleared by the FDA?

Manan Greene Needle (K851835) received a 510(k) decision of Substantially Equivalent on May 17, 1985, 19 days after the submission was received.

What is the product code of K851835?

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