Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
FDA 510(k) K223616 · Boston Scientific Corporation
510(k) numberK223616
Submission
- Device name
- Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- December 5, 2022
- Decision date
- December 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device cleared by the FDA?
Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) received a 510(k) decision of Substantially Equivalent on December 30, 2022, 25 days after the submission was received.
What is the product code of K223616?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.