INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
FDA 510(k) clearance K961940 · decided 1996-07-10
Clearance details
- K-number
- K961940
- Device name
- INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
- Applicant
- Innerdyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-20
- Decision date
- 1996-07-10
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - recall (Z-1387-2023) | Covidien, LP | 2023-04-12 |