Interson Disposable Biopsy Needle
FDA 510(k) K911464 · Interson Corp.
510(k) numberK911464
Submission
- Device name
- Interson Disposable Biopsy Needle
- Applicant
- Interson Corp.
Pleasanton, CA, US - Received
- April 3, 1991
- Decision date
- September 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Decision |
|---|---|---|
| K233734 | Interson USB Ultrasound SystemIYN · Special | 12/22/2023SE |
| K163443 | Interson USB Ultrasound SystemIYN · Traditional | 04/13/2017SE |
| K911116 | Interson Endocavity Probe/Kontron Ultrasound SystITX · Traditional | 12/20/1991SE |
| K911117 | Interson Endocavity Probe for Atl Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911115 | Interson Transrectal Probe/Atl Ultrasound SystemITX · Traditional | 12/17/1991SE |
| K911113 | Interson Transrectal Probe/Kontron Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911114 | Interson Endocavity Probe/Aloka Ultrasound SystemITX · Traditional | 11/19/1991SE |
| K900555 | Interson Multiplane Rectal Probe for Aloka Ultra.ITX · Traditional | 05/02/1990SE |
| K896680 | Probe Sheath for Adms & Capistrano Labs Transrec.FED · Traditional | 02/14/1990SE |
| K895725 | Biopsy Needle Guide for Adms Ultrasound ProbesFCG · Traditional | 11/06/1989SE |
Questions and answers
When was Interson Disposable Biopsy Needle cleared by the FDA?
Interson Disposable Biopsy Needle (K911464) received a 510(k) decision of Substantially Equivalent on September 27, 1991, 177 days after the submission was received.
What is the product code of K911464?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.