Meriglu Topical Skin Adhesive
Device Facts
| Record ID | K230981 |
|---|---|
| Device Name | Meriglu Topical Skin Adhesive |
| Applicant | M/s. Meril Endo Surgery Private Limited. |
| Product Code | MPN · General, Plastic Surgery |
| Decision Date | Mar 16, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4010 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b) *Tissue adhesive for non-topical use* —(1)*Identification.* A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.
