Single Use Hot Biopsy Forceps FD-231
FDA 510(k) clearance K173495 · decided 2018-11-30
Clearance details
- K-number
- K173495
- Device name
- Single Use Hot Biopsy Forceps FD-231
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-13
- Decision date
- 2018-11-30
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- QEC
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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.