The following data is part of a premarket notification filed by Karl Storz Endoscopy America with the FDA for Flexible Intubation Video Endoscope – Sterile (five-s).
| Device ID | K212656 |
| 510k Number | K212656 |
| Device Name: | Flexible Intubation Video Endoscope – Sterile (FIVE-S) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Mario Trujillo |
| Correspondent | Mario Trujillo KARL STORZ Endoscopy America 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2021-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551446584 | K212656 | 000 |