TROCAR AND CANNULA ACCESSORY
FDA 510(k) clearance K945741 · decided 1995-02-28
Clearance details
- K-number
- K945741
- Device name
- TROCAR AND CANNULA ACCESSORY
- Applicant
- Applied Medical Resources
- Decision
- Substantially Equivalent
- Date received
- 1994-11-23
- Decision date
- 1995-02-28
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Launa Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Sepa recall (Z-0023-2009) | Applied Medical Resources Corp | 2008-10-07 |
| Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator S recall (Z-0024-2009) | Applied Medical Resources Corp | 2008-10-07 |
| Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separa recall (Z-0025-2009) | Applied Medical Resources Corp | 2008-10-07 |
| Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator recall (Z-0026-2009) | Applied Medical Resources Corp | 2008-10-07 |