Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
K242204 is the FDA 510(k) clearance record for Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC), a class II device, cleared for Dongguan Quanding Medical Supplies Co., Ltd. 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 one 510(k) clearance for Dongguan Quanding Medical Supplies Co., Ltd. As of , FDA records show no recalls naming K242204.
Clearance record
- Decision date
- Received
- (61 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
- Dongguan Quanding Medical Supplies Co., Ltd. #3 Yongfa E. Rd., Dongguan, CN
- 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 |
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.
