Flexible Intubation Video Endoscope – Sterile (FIVE-S)
FDA 510(k) clearance K212656 · decided 2021-12-29
Clearance details
- K-number
- K212656
- Device name
- Flexible Intubation Video Endoscope – Sterile (FIVE-S)
- Applicant
- Karl Storz Endoscopy America
- Decision
- Substantially Equivalent
- Date received
- 2021-08-23
- Decision date
- 2021-12-29
- Days to decision
- 128 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Karl Storz Endoscopy America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only recall (Z-2589-2023) | Karl Storz Endoscopy | 2023-09-15 |