510(k) K191538
K191538 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Resectr Tissue Resection Device". The FDA issued a decision of Substantially Equivalent on Jan 16, 2020. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 2020
- Date Received
- Jun 10, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type
- 510(k)