COVIDIEN EXTENDED TIP APPLICATOR
FDA 510(k) clearance K091315 · decided 2009-06-05
Clearance details
- K-number
- K091315
- Device name
- COVIDIEN EXTENDED TIP APPLICATOR
- Applicant
- Confluent Surgical,Inc
- Decision
- Substantially Equivalent
- Date received
- 2009-05-04
- Decision date
- 2009-06-05
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Confluent Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Extended Tip Applicator, 8CM, Box of 5. recall (Z-1958-2025) | Integra LifeSciences Corp. (NeuroSciences) | 2025-06-20 |
| Extended Tip Applicator, 15 CM, Box of 5. recall (Z-1959-2025) | Integra LifeSciences Corp. (NeuroSciences) | 2025-06-20 |
| Extended Tip Applicator 8CM, Box of 1. recall (Z-1960-2025) | Integra LifeSciences Corp. (NeuroSciences) | 2025-06-20 |