Sleeved IC
FDA 510(k) clearance K220667 · decided 2022-12-08
Clearance details
- K-number
- K220667
- Device name
- Sleeved IC
- Applicant
- Hollister Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2022-03-07
- Decision date
- 2022-12-08
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- EZD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Libertyville, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.