Padlock Clip defect closure system, Padlock Pro-Select defect closure device
FDA 510(k) clearance K192722 · decided 2019-10-24
Clearance details
- K-number
- K192722
- Device name
- Padlock Clip defect closure system, Padlock Pro-Select defect closure device
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2019-10-24
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.