Karl Storz Endoscopy America, Inc. · Class II · Cleared Jun 23, 2023
| K-number | K230359 |
| Device name | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- |
| Applicant | Karl Storz Endoscopy America, Inc. |
| Product code | GCJ |
| Device class | Class II |
| Decision date | Jun 23, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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