Gramsmed, LLC: FDA clearances and approvals
Gramsmed, LLC has 7 FDA 510(k) clearances (first 2000, latest 2002), across 6 product codes in 1 review panel. Median 510(k) review time: 83 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 2 | 2 |
| GAL | Suture, Absorbable, Natural | 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 Gramsmed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021043 | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | GAL | 2002-06-21 | 81 |
| K010672 | MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE | GAM | 2001-05-18 | 73 |
| K003017 | GRAMSORB SYNTHETIC ABSORBABLE SUTURE | GAM | 2001-03-13 | 167 |
| K003590 | GRAMS POLYESTER NONABSORBABLE SUTURE | GAT | 2001-03-05 | 104 |
| K003000 | GRAMS NYLON NONABSORBABLE SUTURE | GAR | 2000-12-18 | 83 |
| K002999 | GRAMS POLYPROPYLENE NONABSORBABLE SUTURE | GAW | 2000-12-18 | 83 |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | GAP | 2000-12-15 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Gramsmed, LLC.
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 Gramsmed, LLC have?
Gramsmed, LLC has 7 FDA 510(k) clearances (first 2000, latest 2002), across 6 product codes in 1 review panel.
How long does FDA take to clear Gramsmed, LLC's 510(k)s?
The median time from FDA receipt to decision across Gramsmed, LLC's cleared 510(k)s is 83 days.
What devices does Gramsmed, LLC make?
Its most frequent FDA product codes are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 2); GAL (Suture, Absorbable, Natural, 1); GAP (Suture, Nonabsorbable, Silk, 1).
Has Gramsmed, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Gramsmed, LLC. Related entities may recall under other names.
Next steps
- See all 7 Gramsmed, LLC clearances with predicates and recalls
- Run predicate analysis for product code GAM, Gramsmed, LLC'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.