510(k) K112378
K112378 is an FDA 510(k) premarket notification submitted by Cobes Industries Co., Ltd. for the device "COBES SURGICAL DRAPE". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. Cobes Industries Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2012
- Date Received
- August 18, 2011
- 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.