LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
FDA 510(k) clearance K011016 · decided 2001-04-27
Clearance details
- K-number
- K011016
- Device name
- LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
- Applicant
- Lsi Solutions
- Decision
- Substantially Equivalent
- Date received
- 2001-04-04
- Decision date
- 2001-04-27
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Kno recall (Z-0698-05) | Wilson-Cook Medical Inc | 2005-04-08 |