510(k) K253572
K253572 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type