MEDISYSTEMS BUTTONHOLE NEEDLE SETS
FDA 510(k) clearance K990803 · decided 2000-01-06
Clearance details
- K-number
- K990803
- Device name
- MEDISYSTEMS BUTTONHOLE NEEDLE SETS
- Applicant
- Medisystems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-10
- Decision date
- 2000-01-06
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- FIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usag recall (Z-0714-2013) | Medisystems a NX Stage Company | 2013-01-24 |