510(k) K243897
K243897 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture". The FDA issued a decision of Substantially Equivalent on November 12, 2025. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2025
- Date Received
- December 19, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type