PiccGuard
FDA 510(k) clearance K191195 · decided 2020-01-03
Clearance details
- K-number
- K191195
- Device name
- PiccGuard
- Applicant
- Piccguard, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-05-03
- Decision date
- 2020-01-03
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- PZW
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Beloit, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Piccguard
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 |
|---|---|---|
| 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large (K220507) | 3M Company | 2022-05-23 |
Recalls involving this device
No recalls on record reference this clearance.