EndoGator Endoscopy Irrigation Tubing— 510(k) K220395
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K220395 for EndoGator Endoscopy Irrigation Tubing, Substantially Equivalent on 2022-03-11. Applicant: STERIS Corporation. Device class: 2.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code FEQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Recent devices under product code FEQ
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- K182258 — AquaShield System CO2; AquaShield System CO2 - PENTAX; AquaShield System CO2 - Fujifilm
- K173650 — AquaShield System CO2- Fujifilm
- K163424 — AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
- K162152 — Erbes CO2 Tubing/Cap Sets
More clearances from STERIS Corporation
view allAdverse events under product code FEQ
product code FEQ- Malfunction
- 1,135
- Total
- 1,135
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.