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Erbe’s CO2 Tubing/Cap Sets

K162152 Class II Special
Decision Date
2016-08-31
Sponsor / Applicant
Erbe USA, Inc.

Technical Specification

510(k) Submission ID K162152
Product Code FEQ
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1500
Decision Date 2016-08-31
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Erbe’s CO2 Tubing/Cap Sets received FDA 510(k) clearance under submission number K162152, sponsored by Erbe USA, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-08-31.

Classification & Regulation

This clearance is catalogued under FDA product code FEQ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.