Pro-Cut Biopsy Needle

FDA 510(k) K891777 · Teknar, Inc.

Substantially Equivalent

510(k) numberK891777

Submission

Device name
Pro-Cut Biopsy Needle
Applicant
Teknar, Inc.
Fenton, MO, US
Received
March 24, 1989
Decision date
May 4, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional Cook Ireland, Ltd.07/29/2024SE
K231422Precision GIFCG · Traditional Limaca Medical, Ltd.08/28/2023SE
K231267ClearTipFCG · Traditional Finemedix Co., Ltd.06/30/2023SE
K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional Cook Ireland, Ltd.05/30/2023SE
K212423EndoDrill® Model XFCG · Traditional Bibbinstruments AB03/29/2023SE
K212822Disposable Coaxial Biopsy NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K212819Disposable Biopsy Refill NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional Cook Ireland, Ltd.05/20/2021SE

More from Cook Ireland, Ltd.

510(k)DeviceDecision
K903666Ophthasonic A/P IIIHPY · Traditional 11/19/1990SE
K896038B-Scan 10 MHZ ProbeITX · Traditional 04/23/1990SE
K896150Image 2000 System, Imaging, Ultra-SonicIYO · Traditional 01/18/1990SE
K883965Probe, Imaging, Ultrasonic, Mechanical SectorIYO · Traditional 10/05/1988SE
K881850Teknar Percu-ScanIYO · Traditional 08/29/1988SE
K881605Biopsy GuideIYO · Traditional 06/21/1988SE
K880659Teknar Proscan Accessory ProbeIYO · Traditional 04/14/1988SE
K871536Ophthasonic A-Scan/ B-ScanIYO · Traditional 08/26/1987SN
K864807Teknar Proscan(Tm)IYO · Traditional 07/10/1987SE
K860757Ophthasonic A-ScanIYO · Traditional 12/18/1986SE

Questions and answers

When was Pro-Cut Biopsy Needle cleared by the FDA?

Pro-Cut Biopsy Needle (K891777) received a 510(k) decision of Substantially Equivalent on May 4, 1989, 41 days after the submission was received.

What is the product code of K891777?

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