Purgo Biologics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Purgo Biologics, Inc.” (first 2018, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 279 days. Since 2017 the median was 279 days, against 208 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 291 |
| 2019 | 1 | 456 |
| 2020 | 1 | 231 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 264 |
| 2024 | 1 | 537 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Purgo Biologics, Inc. took a median 279 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | 3 | 3 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 | 1 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
Review panels
Most recent Purgo Biologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230305 | THE Graft Collagen | NPM | 2024-07-24 | 537 |
| K230091 | THE Cover | NPL | 2023-10-06 | 267 |
| K222549 | OpenTex | NPK | 2023-05-11 | 261 |
| K191737 | The Graft Bone Substitute | NPM | 2020-02-14 | 231 |
| K180992 | Biotex | NBY | 2019-07-16 | 456 |
| K173188 | The Graft Natural Bone Substitute | NPM | 2018-07-20 | 291 |
Recalls
openFDA lists no recalls under a recalling firm named Purgo Biologics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Purgo Biologics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Purgo Biologics, Inc.” (first 2018, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Purgo Biologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Purgo Biologics, Inc. is 279 days. Since 2017: 279 days, versus 208 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Purgo Biologics, Inc.?
The most frequent FDA product codes under this applicant name are NPM (Bone Grafting Material, Animal Source, 3); NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, 1); NPK (Barrier, Synthetic, Intraoral, 1).
Next steps
- See all 6 Purgo Biologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NPM, Purgo Biologics, Inc.'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.