XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
FDA 510(k) clearance K170334 · decided 2017-05-01
Clearance details
- K-number
- K170334
- Device name
- XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
- Applicant
- Revmedx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-02
- Decision date
- 2017-05-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PGZ
- Device class
- 2
- Regulation number
- 878.4452
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wilsonville,, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Revmedx
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 |
|---|---|---|
| XSTAT P15 (K253290) | Revmedx, Inc. | 2025-11-12 |
| XSTAT 30 Pouch (K210676) | Revmedx, Inc. | 2021-08-27 |
| XSTAT 30, 1-Pack (K180051) | Revmedx, Inc. | 2018-05-18 |
| XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (K161020) | Revmedx, Inc. | 2016-07-28 |
| XSTAT 30, 3-PACK, XSTAT 30, 1-PACK (K152624) | Revmedx, Inc. | 2015-12-07 |
| XSTAT (DEN130016) | Revmedx, Inc. | 2014-04-03 |
Recalls involving this device
No recalls on record reference this clearance.