Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
FDA 510(k) K212852 · Micro-Tech (Nanjing) Co., Ltd.
Submission
- Device name
- Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- September 7, 2021
- Decision date
- December 6, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODG – Endoscopic Ultrasound System, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260428 | RIVOS EUS Access Device (M00553900)ODG · Traditional | Boston Scientific Corporation | 06/17/2026SE |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 10/03/2025SE |
| K251542 | InstaFANODG · Traditional | Onepass Medical , Ltd. | 07/18/2025SE |
| K231813 | Ultrasonic GastrovideoscopeODG · Traditional | Sonoscape Medical Corp. | 03/08/2024SE |
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| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODG · Special | Boston Scientific Corporation | 12/30/2022SE |
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| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580URODG · Special | Fujifilm Corporation | 08/04/2022SE |
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Questions and answers
When was Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle cleared by the FDA?
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle (K212852) received a 510(k) decision of Substantially Equivalent on December 6, 2021, 90 days after the submission was received.
What is the product code of K212852?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.