Suction Guillotine Device

FDA 510(k) K932142 · Triton Technology, Inc.

Substantially Equivalent

510(k) numberK932142

Submission

Device name
Suction Guillotine Device
Applicant
Triton Technology, Inc.
Salem, OH, US
Received
May 3, 1993
Decision date
September 24, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K911448Multiple Biopsy Device-MbxFCK · Traditional Triton Technology, Inc.04/16/1991SE
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
K911448Multiple Biopsy Device-MbxFCK · Traditional 04/16/1991SE
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Questions and answers

When was Suction Guillotine Device cleared by the FDA?

Suction Guillotine Device (K932142) received a 510(k) decision of Substantially Equivalent on September 24, 1993, 144 days after the submission was received.

What is the product code of K932142?

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