Internacional Farmaceutica, S.A. DE C.V.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Internacional Farmaceutica, S.A. DE C.V.” (first 1991, latest 2008), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 1 | 1 |
Review panels
Most recent Internacional Farmaceutica, S.A. DE C.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | GAM | 2008-05-23 | 231 |
| K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | GAM | 2008-05-23 | 231 |
| K041048 | POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE | NEW | 2004-06-04 | 43 |
| K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID | GAM | 2004-04-29 | 83 |
| K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT | GAQ | 1991-12-04 | 139 |
| K911354 | STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES | GAL | 1991-10-25 | 213 |
| K911189 | STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE | GAW | 1991-04-25 | 38 |
| K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES | GAP | 1991-02-11 | 77 |
| K905286 | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES | GAR | 1991-02-11 | 77 |
| K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | GAS | 1991-02-11 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Internacional Farmaceutica, S.A. DE C.V..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Internacional Farmacéutica S.A DE C.V (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Internacional Farmaceutica, S.A. DE C.V.?
FDA lists 10 510(k) clearances under the applicant name “Internacional Farmaceutica, S.A. DE C.V.” (first 1991, latest 2008), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Internacional Farmaceutica, S.A. DE C.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Internacional Farmaceutica, S.A. DE C.V. is 80 days.
Which FDA product codes appear under Internacional Farmaceutica, S.A. DE C.V.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAL (Suture, Absorbable, Natural, 1); GAP (Suture, Nonabsorbable, Silk, 1).
Next steps
- See all 10 Internacional Farmaceutica, S.A. DE C.V. clearances with predicates and recalls
- Run predicate analysis for product code GAM, Internacional Farmaceutica, S.A. DE C.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.