POINT SETTER
FDA 510(k) clearance K984355 · decided 1999-04-01
Clearance details
- K-number
- K984355
- Device name
- POINT SETTER
- Applicant
- Mitaka USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-07
- Decision date
- 1999-04-01
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Park City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments recall (Z-1539-2012) | Mitaka USA, Inc. | 2012-05-11 |