510(k) K121436
K121436 is an FDA 510(k) premarket notification submitted by Das Medical, LLC for the device "DAS MEDICAL EQUIPMENT DRAPES". The FDA issued a decision of Substantially Equivalent on June 6, 2013. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2013
- Date Received
- May 15, 2012
- 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.