The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Clickline Scissor Insert For Single Use.
| Device ID | K151044 |
| 510k Number | K151044 |
| Device Name: | CLICKLINE Scissor Insert For Single Use |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-10-09 |
| Summary: | summary |