REPROCESSED TROCARS, MODEL B5LT AND CB5LT
FDA 510(k) clearance K100080 · decided 2010-03-19
Clearance details
- K-number
- K100080
- Device name
- REPROCESSED TROCARS, MODEL B5LT AND CB5LT
- Applicant
- Ascent Healthcare Solutions
- Decision
- Substantially Equivalent
- Date received
- 2010-01-12
- Decision date
- 2010-03-19
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/St recall (Z-2468-2015) | Stryker Sustainability Solutions | 2015-08-27 |