Cleared Traditional

K230488 - EL27-Compact

Also marketed or referenced as:
Sterile EHL-Probes

K230488 is an FDA 510(k) clearance for EL27-Compact, manufactured by Walz Elektronik GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K230488 · Walz Elektronik GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
189d
Days
Class 2
Risk

K230488 is an FDA 510(k) clearance for the EL27-Compact. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Walz Elektronik GmbH (Rohrdorf, DE). The FDA issued a Cleared decision on August 31, 2023 after a review of 189 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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 Walz Elektronik GmbH devices

FDA 510(k) Submission Details - K230488

510(k) Number K230488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2023
Decision Date August 31, 2023
Days to Decision 189 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
59d slower than avg
Panel avg: 130d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFK Device Classification - Class 2, Special Controls

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FFK Lithotriptor, Electro-hydraulic

All 30
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K230488.
Electrohydraulic Lithotriptor (TCS-B3-II)
K242888 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Mar 2025
EHL Probe (SCDG-AS)
K243032 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Mar 2025
URO-TOUCH 9 French Probe
K202813 · Northgate Technologies, Inc. · Jun 2021
Swiss LithoClast Trilogy
K191124 · E.M.S Electro Medical Systems S.A · May 2019
AUTOLITH TOUCH
K130368 · Northgate Technologies, Inc. · Nov 2013
SWISS LITHOBREAKER
K123038 · E.M.S Electro Medical Systems S.A · Jan 2013