Multiple Biopsy Device-Mbx

FDA 510(k) K911448 · Triton Technology, Inc.

Substantially Equivalent

510(k) numberK911448

Submission

Device name
Multiple Biopsy Device-Mbx
Applicant
Triton Technology, Inc.
Salem, OH, US
Received
March 15, 1991
Decision date
April 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K062159RB12 Suction Rectal Biopsy SystemFCK · Traditional Aus Systems Pty , Ltd.09/05/2006SE
K061201Dsnare Diminutive Polypectomy and Suction System, Model 00711087FCK · Special United States Endoscopy Group, Inc.05/30/2006SE
K051637Dsnare, Model 00711087FCK · Traditional United States Endoscopy Group, Inc.10/31/2005SE
K954693Mehta Bronchial Biospy DrillFCK · Traditional United States Endoscopy Group, Inc.10/23/1995SE
K944252Biopsy Device AccessoryFCK · Traditional Biopsys Medical, Inc.12/05/1994SE
K932142Suction Guillotine DeviceFCK · Traditional Triton Technology, Inc.09/24/1993SE
K902910CytoaspiratorFCK · Traditional H & B Medical Technology, Inc.01/16/1991SE
K902097Model TR Rectal Suction Biopsy TubeFCK · Traditional Medical Measurements, Inc.07/27/1990SE

More from Medical Measurements, Inc.

510(k)DeviceDecision
K932142Suction Guillotine DeviceFCK · Traditional 09/24/1993SE
K902883Tissue/Polyp Trap SystemBYZ · Traditional 09/12/1990SE
K881303Triton Model 100 Pulsed Doppler Blood FlowmeterDPT · Traditional 11/29/1988SE

Questions and answers

When was Multiple Biopsy Device-Mbx cleared by the FDA?

Multiple Biopsy Device-Mbx (K911448) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 32 days after the submission was received.

What is the product code of K911448?

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