Flexible Intubation Video Endoscope Sterile (FIVE-S)— 510(k) K212656
Substantially EquivalentKarl Storz Endoscopy America
FDA 510(k) clearance K212656 for Flexible Intubation Video Endoscope Sterile (FIVE-S), Substantially Equivalent on 2021-12-29. Applicant: Karl Storz Endoscopy America. Device class: 2.
Clearance details
- Applicant
- Karl Storz Endoscopy America
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- El Segundo, CA, US
Recent devices under product code EOQ
view allMore clearances from Karl Storz Endoscopy America
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K212656
K-number listed on FDA's recall record- Z-2589-2023 — Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Z-1055-2022 — 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212656.
Data sourced from openFDA. This site is unofficial and independent of the FDA.