Trading Consultants and Distributors Intl., Inc.: FDA clearances and approvals
Trading Consultants and Distributors Intl., Inc. has 6 FDA 510(k) clearances (first 2000, latest 2000), across 6 product codes in 1 review panel. Median 510(k) review time: 72 days.
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 |
|---|---|---|---|
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Trading Consultants and Distributors Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994001 | POLYGLYCOLIC ACID | GAM | 2000-02-09 | 77 |
| K994002 | PLAIN/CHROMIC CATGUT | GAL | 2000-02-04 | 72 |
| K994000 | POLYESTER | GAT | 2000-02-04 | 72 |
| K993999 | SILK | GAP | 2000-02-04 | 72 |
| K993998 | NYLON | GAR | 2000-02-04 | 72 |
| K993997 | POLYPROPYLENE | GAW | 2000-02-04 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Trading Consultants and Distributors Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Trading Consultants and Distributors Intl., Inc. have?
Trading Consultants and Distributors Intl., Inc. has 6 FDA 510(k) clearances (first 2000, latest 2000), across 6 product codes in 1 review panel.
How long does FDA take to clear Trading Consultants and Distributors Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Trading Consultants and Distributors Intl., Inc.'s cleared 510(k)s is 72 days.
What devices does Trading Consultants and Distributors Intl., Inc. make?
Its most frequent FDA product codes are GAL (Suture, Absorbable, Natural, 1); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 1); GAP (Suture, Nonabsorbable, Silk, 1).
Has Trading Consultants and Distributors Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Trading Consultants and Distributors Intl., Inc. Related entities may recall under other names.
Next steps
- See all 6 Trading Consultants and Distributors Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAL, Trading Consultants and Distributors Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.