SUCTION IRRIGATION ELECTRODES AND ADAPTERS
FDA 510(k) clearance K100711 · decided 2010-06-09
Clearance details
- K-number
- K100711
- Device name
- SUCTION IRRIGATION ELECTRODES AND ADAPTERS
- Applicant
- Encision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-12
- Decision date
- 2010-06-09
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boulder, CO, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Encision
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 |
|---|---|---|
| Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc., Boulder, recall (Z-3093-2011) | Encision, Inc. | 2011-08-30 |
| Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc., Boulder, CO recall (Z-3094-2011) | Encision, Inc. | 2011-08-30 |
| Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder, CO recall (Z-3095-2011) | Encision, Inc. | 2011-08-30 |
| Encision AEM Suction Irrigation Electrode, J-Hook, REF ES3884. Encision Inc., Boulder, CO recall (Z-3096-2011) | Encision, Inc. | 2011-08-30 |
| Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, recall (Z-3097-2011) | Encision, Inc. | 2011-08-30 |