Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
FDA 510(k) K173184 · Boston Scientific
510(k) numberK173184
Submission
- Device name
- Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- Applicant
- Boston Scientific
Marlboro, MA, US - Received
- September 29, 2017
- Decision date
- October 27, 2017
- 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 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle cleared by the FDA?
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K173184) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 28 days after the submission was received.
What is the product code of K173184?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.