Newton, MA, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | Class II | General, Plastic Surgery | 3 | 2026-08-03 |
| PHN | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | Unclassified | Unknown | 2 | 2026-08-03 |
| OLR | Oral Wound Dressing | Unclassified | Unknown | 1 | 2021-10-08 |
| FRO | Dressing, Wound, Drug | Unclassified | Unknown | 1 | 2020-05-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-03 | K261504 | PuraStat-RM | PHN | Unclassified | Unknown |
| 2026-08-03 | K261503 | PuraStat GI | QAU | Class II | General, Plastic Surgery |
| 2023-02-28 | K222481 | PuraStat | QAU | Class II | General, Plastic Surgery |
| 2022-04-01 | K213552 | PuraStat-RM | PHN | Unclassified | Unknown |
| 2021-10-08 | K210211 | PuraStat-OM | OLR | Unclassified | Unknown |
| 2021-06-25 | K210098 | PuraStat-GI | QAU | Class II | General, Plastic Surgery |
| 2020-05-11 | K193085 | PuraDERM Gel | FRO | Unclassified | Unknown |