510(k) K190639
K190639 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Endosee System". The FDA issued a decision of Substantially Equivalent on May 15, 2019. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2019
- Date Received
- March 13, 2019
- Clearance Type
- Special
- 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