510(k) K010711
K010711 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts (Asc) for the device "ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR". The FDA issued a decision of Substantially Equivalent on May 22, 2001. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Advanced Surgical Concepts (Asc) has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2001
- Date Received
- March 9, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Surgical, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.