ORIGIN BLUNT TIP SURGICAL TROCAR
FDA 510(k) clearance K924011 · decided 1993-07-09
Clearance details
- K-number
- K924011
- Device name
- ORIGIN BLUNT TIP SURGICAL TROCAR
- Applicant
- Origin Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-10
- Decision date
- 1993-07-09
- Days to decision
- 333 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB recall (Z-1465-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL recall (Z-1466-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL recall (Z-1467-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT recall (Z-1468-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS recall (Z-1469-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT recall (Z-1470-2024) | Covidien, LP | 2024-04-03 |
| Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL recall (Z-1471-2024) | Covidien, LP | 2024-04-03 |