510(k) K192330
K192330 is an FDA 510(k) premarket notification submitted by Covidien for the device "EEA Circular Stapler with Tri-Staple Technology". The FDA issued a decision of Substantially Equivalent on Jan 23, 2020. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2020
- Date Received
- Aug 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type
- 510(k)