LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
FDA 510(k) clearance K070315 · decided 2007-10-30
Clearance details
- K-number
- K070315
- Device name
- LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
- Applicant
- Lina Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2007-02-01
- Decision date
- 2007-10-30
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- KNF
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chapel Hill, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Lar recall (Z-2688-2011) | LINA Medical ApS | 2011-06-28 |
| LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Sma recall (Z-2689-2011) | LINA Medical ApS | 2011-06-28 |
| LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Lar recall (Z-2690-2011) | LINA Medical ApS | 2011-06-28 |