KII TROCAR SYSTEM
FDA 510(k) clearance K072674 · decided 2007-10-05
Clearance details
- K-number
- K072674
- Device name
- KII TROCAR SYSTEM
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-21
- Decision date
- 2007-10-05
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optic recall (Z-2533-2017) | Applied Medical Resources Corp | 2017-06-14 |
| Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thora recall (Z-0644-2013) | Applied Medical Resources Corp | 2013-01-07 |