Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe
K944861 is the FDA 510(k) clearance record for KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)). FDA's definition for product code EOB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K944861.
Clearance record
- Decision date
- Received
- (141 days to decision)
- Product code
- EOB Nasopharyngoscope (Flexible Or Rigid)
- Regulation
- 21 CFR 874.4760
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Applicant
- KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code EOB
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 2 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 1 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
| November 2026 | 0 |
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