Sonotip II Ultrasound Needle System
FDA 510(k) K070129 · Medi-Globe Corporation
510(k) numberK070129
Submission
- Device name
- Sonotip II Ultrasound Needle System
- Applicant
- Medi-Globe Corporation
Tempe, AZ, US - Received
- January 16, 2007
- Decision date
- January 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional | Olympus Medical Systems Corp. | 10/24/2025SE |
| K250994 | ClearTip FNA and FNB TypesFCG · Traditional | Finemedix Co., Ltd. | 08/21/2025SE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional | Cook Ireland, Ltd. | 07/29/2024SE |
| K231422 | Precision GIFCG · Traditional | Limaca Medical, Ltd. | 08/28/2023SE |
| K231267 | ClearTipFCG · Traditional | Finemedix Co., Ltd. | 06/30/2023SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | Cook Ireland, Ltd. | 05/30/2023SE |
| 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 |
More from Cook Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | 04/16/2026SE |
| K153264 | EasyPass GuidewireOCY · Traditional | 05/19/2016SE |
| K142258 | PolyCatch Retrieval DeviceFDI · Traditional | 09/30/2014SE |
| K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemFCG · Traditional | 05/15/2014SE |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle SystemFCG · Traditional | 05/08/2009SE |
| K083802 | Sonotip II 25-GAUGE Ultrasound Needle System, Models GUS-01-18-025 and GUS-01-27-025FCG · Traditional | 03/20/2009SE |
| K061222 | Injectra Injection NeedleFBK · Traditional | 07/03/2006SE |
| K061684 | Medi-Globe Rota-Cut SphincterotomeKNS · Traditional | 06/27/2006SE |
| K051247 | Sonotip II Ultrasound Needle SystemFCG · Special | 06/16/2005SE |
| K011261 | Stone Extractor Balloon CatheterFGE · Traditional | 11/17/2003SE |
Questions and answers
When was Sonotip II Ultrasound Needle System cleared by the FDA?
Sonotip II Ultrasound Needle System (K070129) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 15 days after the submission was received.
What is the product code of K070129?
The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.