EndoGator Endoscopy Irrigation Tubing
FDA 510(k) clearance K220395 · decided 2022-03-11
Clearance details
- K-number
- K220395
- Device name
- EndoGator Endoscopy Irrigation Tubing
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-02-11
- Decision date
- 2022-03-11
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- 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.