SAVARY-GILLIARD DILATOR
FDA 510(k) clearance K851955 · decided 1985-07-25
Clearance details
- K-number
- K851955
- Device name
- SAVARY-GILLIARD DILATOR
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-03
- Decision date
- 1985-07-25
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- KNQ
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable recall (Z-0441-06) | Cook Endoscopy | 2006-01-25 |