Endoscopic Ultrasound Aspiration Needle
FDA 510(k) K172309 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK172309
Submission
- Device name
- Endoscopic Ultrasound Aspiration Needle
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- July 31, 2017
- Decision date
- September 29, 2017
- 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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| K231813 | Ultrasonic GastrovideoscopeODG · Traditional | Sonoscape Medical Corp. | 03/08/2024SE |
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Questions and answers
When was Endoscopic Ultrasound Aspiration Needle cleared by the FDA?
Endoscopic Ultrasound Aspiration Needle (K172309) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 60 days after the submission was received.
What is the product code of K172309?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.