STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES— 510(k) K911354
Substantially EquivalentInternacional Farmaceutica, S.A. DE C.V.
FDA 510(k) clearance K911354 for STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES, Substantially Equivalent on 1991-10-25. Applicant: Internacional Farmaceutica, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
- Product code
- Code GAL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- 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 GAL
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- 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 GAL
product code GAL- Malfunction
- 681
- Other
- 1
- Total
- 682
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.