The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for 11.
| Device ID | K222504 |
| 510k Number | K222504 |
| Device Name: | 11 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Karl Storz Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Mario Trujillo |
| Correspondent | Winkie Wong Karl Storz Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-11-10 |