IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES— 510(k) K905287
Substantially EquivalentInternacional Farmaceutica, S.A. DE C.V.
FDA 510(k) clearance K905287 for IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES, Substantially Equivalent on 1991-02-11. Applicant: Internacional Farmaceutica, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
- Product code
- Code GAP
- Device class
- Class 2
- Regulation
- 21 CFR 878.5030
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
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More 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 GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
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.