STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE— 510(k) K911189
Substantially EquivalentInternacional Farmaceutica, S.A. DE C.V.
FDA 510(k) clearance K911189 for STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE, Substantially Equivalent on 1991-04-25. Applicant: Internacional Farmaceutica, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
- Product code
- Code GAW
- Device class
- Class 2
- Regulation
- 21 CFR 878.5010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code GAW
view allMore clearances from Internacional Farmaceutica, S.A. DE C.V.
view all- K072859 — ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
- K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
- K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K040282 — ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
- K913185 — STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
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.