Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model Ep 211M
K071080 is the FDA 510(k) clearance record for ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M, a class II device, cleared for E Surgical, LLC 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 5 510(k) clearances for E Surgical, LLC, from to . As of , FDA records show no recalls naming K071080.
Clearance record
- Decision date
- Received
- (136 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
- E Surgical, LLC 1910 N. California Blvd., Walnut Creek CA
- 510(k) summary
- Summary PDF
- Third party review
- No
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 |
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