Meriglu Topical Skin Adhesive— 510(k) K230981
Substantially EquivalentM/s. Meril Endo Surgery Private Limited.
FDA 510(k) clearance K230981 for Meriglu Topical Skin Adhesive, Substantially Equivalent on 2024-03-16. Applicant: M/s. Meril Endo Surgery Private Limited.. Device class: 2.
Clearance details
- Applicant
- M/s. Meril Endo Surgery Private Limited.
- Product code
- Code MPN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chala, Vapi, IN
Recent devices under product code MPN
view all- K243990 — BondEase 2 Topical Skin Adhesive
- K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)
- K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
- K233458 — CM005 Standard (CM005); CM004 Mini (CM004)
- K212246 — Exofin Precision Pen
More clearances from M/s. Meril Endo Surgery Private Limited.
view all- K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- K233386 — Monik - Disposable Endoscopic Trocar
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- K200452 — Meril-Bonewax
- K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
Adverse events under product code MPN
product code MPN- Injury
- 856
- Other
- 1
- Total
- 857
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.