Zip 4 Skin Closure Device
FDA 510(k) clearance K170003 · decided 2017-08-18
Clearance details
- K-number
- K170003
- Device name
- Zip 4 Skin Closure Device
- Applicant
- Zipline Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-03
- Decision date
- 2017-08-18
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- PYO
- Device class
- 1
- Regulation number
- 880.5240
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.