Cleared Traditional

SpydrBlade Flex Instrument (PRD-RG1-001) (K242774) - FDA 510(k) Clearance

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

K242774 · Creo Medical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
266d
Days
Class 2
Risk

K242774 is an FDA 510(k) clearance for the SpydrBlade Flex Instrument (PRD-RG1-001). 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 June 6, 2025 after a review of 266 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 K242774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2024
Decision Date June 06, 2025
Days to Decision 266 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
136d slower than avg
Panel avg: 130d · This submission: 266d
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 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 K242774.
SureTome™ SW Sphincterotome with DomeTip
K251104 · Wilson Cook Medical · Sep 2025
Aqua Medical RF Vapor Ablation System
K251226 · Aqua Medical, Inc. · Aug 2025
Rezum System
K250584 · Boston Scientific Corporation · Jun 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
K241855 · Sb-Kawasumi Laboratories, Inc. · Mar 2025
Disposable Sphincterotome
K242192 · Beijing Zksk Technology Co., Ltd. · Feb 2025
Teslatome Bipolar Sphincterotome
K243568 · Wilson-Cook Medical, Inc. · Jan 2025