Cleared Traditional

K172575 - BAROnova Retrieval Kit

K172575 is the FDA 510(k) clearance for BAROnova Retrieval Kit by Baronova, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K172575 · Baronova, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
143d
Days
Class 2
Risk

K172575 is an FDA 510(k) clearance for the BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Baronova, Inc. (San Carlos, US). The FDA issued a Cleared decision on January 18, 2018 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baronova, Inc. devices

Submission Details

510(k) Number K172575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date January 18, 2018
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K172575.
ReTrace Ureteral Access Sheath
K181811 · Coloplast A/S · Sep 2018
ORISE Tissue Retractor System
K173400 · Boston Scientific · Feb 2018
Trans-anal Introducer
K171208 · Visionsense, Ltd. · Feb 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