Trokabone, Trokabone Sternal
FDA 510(k) K070179 · PAJUNK GmbH Medizintechnologie
510(k) numberK070179
Submission
- Device name
- Trokabone, Trokabone Sternal
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- January 19, 2007
- Decision date
- March 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | Cook Ireland, Ltd. | 05/20/2021SE |
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| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | 09/11/2024SE |
| K230701 | Stim2GoIPF · Traditional | 11/24/2023SE |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special | 02/22/2023SE |
| K220897 | Disposable Brain Biopsy Needle 2.0HAW · Traditional | 08/17/2022SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | 12/29/2020SE |
Questions and answers
When was Trokabone, Trokabone Sternal cleared by the FDA?
Trokabone, Trokabone Sternal (K070179) received a 510(k) decision of Substantially Equivalent on March 7, 2007, 47 days after the submission was received.
What is the product code of K070179?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.