Cleared Traditional

K150083 - Sidecar External Working Channel

K150083 is an FDA 510(k) clearance for Sidecar External Working Channel, manufactured by C2 Therapeutics. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K150083 · C2 Therapeutics · Gastroenterology & Urology device
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Apr 2015
Decision
89d
Days
Class 2
Risk

K150083 is an FDA 510(k) clearance for the Sidecar External Working Channel. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by C2 Therapeutics (Redwood, Ca, US). The FDA issued a Cleared decision on April 14, 2015 after a review of 89 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 C2 Therapeutics devices

FDA 510(k) Submission Details - K150083

510(k) Number K150083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2015
Decision Date April 14, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K150083.
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · Baronova, Inc. · Jan 2018
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
K172217 · Cook Incorporated · Dec 2017
Proxis Ureteral Access Sheath
K160861 · C.R. Bard, Inc. · Mar 2016
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K140523 · Coloplast A/S · Jul 2014
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
K140323 · Boston Scientific · Mar 2014
ANAL RECTAL OVERTUBE
K131598 · United States Endoscopy Group, Inc. · Feb 2014