Symphion Endoscope and Symphion Cervical Sheath
FDA 510(k) K160751 · Boston Scientific
510(k) numberK160751
Submission
- Device name
- Symphion Endoscope and Symphion Cervical Sheath
- Applicant
- Boston Scientific
Marlboro, MA, US - Received
- March 18, 2016
- Decision date
- June 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Symphion Endoscope and Symphion Cervical Sheath cleared by the FDA?
Symphion Endoscope and Symphion Cervical Sheath (K160751) received a 510(k) decision of Substantially Equivalent on June 14, 2016, 88 days after the submission was received.
What is the product code of K160751?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.