510(k) K140343
K140343 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP". The FDA issued a decision of Substantially Equivalent on May 13, 2014. The device falls under product code MPN (Tissue Adhesive For The Topical Approximation Of Skin), a Class II device regulated under 21 CFR 878.4010. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2014
- Date Received
- February 11, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Adhesive For The Topical Approximation Of Skin
- Device Class
- Class II
- Regulation Number
- 878.4010
- Review Panel
- SU
- Submission Type
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).