Cleared Traditional

K103235 - ERBEFLO 2 DISPOSABLE TUBING SYSTEM

K103235 is the FDA 510(k) clearance for ERBEFLO 2 DISPOSABLE TUBING SYSTEM by Erbe USA, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K103235 · Erbe USA, Inc. · Gastroenterology & Urology device
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Dec 2010
Decision
51d
Days
Class 2
Risk

K103235 is an FDA 510(k) clearance for the ERBEFLO 2 DISPOSABLE TUBING SYSTEM. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on December 23, 2010 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erbe USA, Inc. devices

Submission Details

510(k) Number K103235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2010
Decision Date December 23, 2010
Days to Decision 51 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 58
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