Cleared Traditional

Creo Electrosurgical System with HS1 Hemostasis Accessory (K192905) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192905 · Creo Medical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
156d
Days
Class 2
Risk

K192905 is an FDA 510(k) clearance for the Creo Electrosurgical System with HS1 Hemostasis Accessory. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Creo Medical, Ltd. (Chepstow, GB). The FDA issued a Cleared decision on March 19, 2020 after a review of 156 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Creo Medical, Ltd. devices

Submission Details

510(k) Number K192905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 15, 2019
Decision Date March 19, 2020
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Consultant

Phil Triolo and Associates LC
Leif Geoghegan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 83
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K192905.
Sphincterotome
K201121 · Hangzhou AGS MedTech Co., Ltd. · Feb 2021
ORISE ProKnife
K200404 · Boston Scientific Corporation · Dec 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
K192342 · Hangzhou AGS MedTech Co., Ltd. · May 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · Wilson-Cook Medical, Inc. · Jan 2020
Single Use Balloon Dilator V (with knife)
K193039 · Olympus Medical Systems Corp. · Dec 2019
Rezum System
K191505 · Nxthera (A Boston Scientific Company) · Aug 2019