Electrosurgical Tip Cleaner, Tip Cleaning Pad, Lectrobrasive Tip Cleaner, Electrosurgical Tip Cleaner, Electrode Tip Cle
K971805 is the FDA 510(k) clearance record for ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE, a class II device, cleared for Aaron Medical Industries 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 75 510(k) clearances for Apyx Medical Corporation, from to . As of , FDA records show no recalls naming K971805.
Clearance record
- Decision date
- Received
- (29 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
- Aaron Medical Industries 7100 30th Ave. N, St. Petersburg FL
- 510(k) summary
- Statement
- 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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