MPN
- Product code
- MPN
- Device name
- Tissue Adhesive For The Topical Approximation Of Skin
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4010
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
FDA classification definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243990 | 2025-09-19 | Optmed, Inc. | BondEase 2 Topical Skin Adhesive | |
| K250950 | 2025-08-04 | Okapi Medical, LLC Dba Resivant Medica… | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS… | |
| K234114 | 2024-08-20 | Okapi Medical, LLC Dba Resivant Medica… | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(T… | |
| K233458 | 2024-07-15 | Connexicon Medical , Ltd. | CM005 Standard (CM005); CM004 Mini (CM004) | |
| K230981 | 2024-03-16 | M/s. Meril Endo Surgery Private Limite… | Meriglu Topical Skin Adhesive | FDA |
Official FDA classification page: MPN
Classification and pathway per current FDA publications. Data from openFDA (CC0).