FDA 510(k) Applications Submitted by Alita McElroy
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200318 |
02/07/2020 |
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece |
Karl Storz Endoscopy-America, Inc. |
| K230535 |
02/27/2023 |
KARL STORZ Urological Laser Accessories |
Karl Storz SE & CO. KG |
| K221004 |
04/05/2022 |
HOPKINS Telescopes |
KARL STORZ Endoscopy America, Inc. |
| K201135 |
04/28/2020 |
Image1 S CCU, Image1 S 4U Camera Head |
Karl Storz Endoscopy-America, Inc. |
| K201399 |
05/28/2020 |
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0░, 30░, 45░, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Opt |
Karl Storz-Endoscopy-America, Inc. |
| K202925 |
09/29/2020 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy_America, Inc. |
| K213194 |
09/29/2021 |
HD Mediastinoscope |
Karl Storz Endoscopy America, Inc. |
| K223520 |
11/23/2022 |
UNIDRIVE SIII System |
Karl Storz-Endoscopy-America, Inc. |
| K223923 |
12/30/2022 |
HOPKINS Telescopes |
KARL STORZ Endoscopy-America, Inc |
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