NuStat
FDA 510(k) clearance K183190 · decided 2019-09-25
Clearance details
- K-number
- K183190
- Device name
- NuStat
- Applicant
- Beeken Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-11-19
- Decision date
- 2019-09-25
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- POD
- Device class
- 2
- Regulation number
- 878.4454
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Stoughton, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beeken Biomedical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QuikClot Control+ Hemostatic Device (K243553) | Teleflex Medical | 2025-03-18 |
| Ax-Surgi Surgical Hemostat (K213198) | Advamedica, Inc. | 2023-01-05 |
| QuikClot Control+ Hemostatic Dressing (K220971) | Z-Medica, LLC | 2022-12-14 |
| QuikClot Control+ (K200167) | Z-Medica, LLC | 2020-04-23 |
| D2 Dressing (DEN160012) | Z-Medica, LLC | 2017-06-30 |
Recalls involving this device
No recalls on record reference this clearance.