Single Use Guide Sheath Kit-401, K-402
FDA 510(k) clearance K212667 · decided 2021-09-22
Clearance details
- K-number
- K212667
- Device name
- Single Use Guide Sheath Kit-401, K-402
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-23
- Decision date
- 2021-09-22
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.