Erbes CO2 Tubing/Cap Sets— 510(k) K162152
Substantially EquivalentErbe USA, Inc.
FDA 510(k) clearance K162152 for Erbes CO2 Tubing/Cap Sets, Substantially Equivalent on 2016-08-31. Applicant: Erbe USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Erbe USA, Inc.
- 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
- Marietta, GA, US
Recent devices under product code FEQ
view all- K220395 — EndoGator Endoscopy Irrigation Tubing
- K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
- 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
More clearances from Erbe USA, Inc.
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 →
Recalls naming K162152
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162152.
Data sourced from openFDA. This site is unofficial and independent of the FDA.