Acuson Transrectal Needle Guide for Intra. Appli.
FDA 510(k) K882549 · Acuson Corp.
510(k) numberK882549
Submission
- Device name
- Acuson Transrectal Needle Guide for Intra. Appli.
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- June 20, 1988
- Decision date
- July 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K212423 | EndoDrill® Model XFCG · Traditional | Bibbinstruments AB | 03/29/2023SE |
| K212822 | Disposable Coaxial Biopsy NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K212819 | Disposable Biopsy Refill NeedleFCG · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
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| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
Questions and answers
When was Acuson Transrectal Needle Guide for Intra. Appli. cleared by the FDA?
Acuson Transrectal Needle Guide for Intra. Appli. (K882549) received a 510(k) decision of Substantially Equivalent on July 21, 1988, 31 days after the submission was received.
What is the product code of K882549?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.