Suction Irrigation Electrodes and Adapters
K100711 is the FDA 510(k) clearance record for SUCTION IRRIGATION ELECTRODES AND ADAPTERS, a class II device, cleared for Encision, Inc. on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 10 510(k) clearances for Encision, Inc., from to . As of , FDA records show 5 recalls naming K100711.
Clearance record
- Decision date
- Received
- (89 days to decision)
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Encision, Inc. 6797 Winchester Cir., Boulder CO
- 510(k) summary
- Summary PDF
- Third party review
- Yes
Clearances, product code GEI
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 4 |
| December 2025 | 1 |
| January 2026 | 6 |
| February 2026 | 3 |
| March 2026 | 5 |
| April 2026 | 5 |
| May 2026 | 4 |
| June 2026 | 9 |
| July 2026 | 3 |
| August 2026 | 2 |
| September 2026 | 5 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
