510(k) K240185
K240185 is an FDA 510(k) premarket notification submitted by Cypris Medical for the device "Cypris eXact Suture Placement Device". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code GEJ (Carrier, Ligature), a Class I device regulated under 21 CFR 878.4800. Cypris Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2024
- Date Received
- January 23, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carrier, Ligature
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type