Cleared Traditional

K172614 - Caldera Medical Transobturator Helical Introducer, Left (FDA 510(k) Clearance)

Also includes:
Caldera Medical Transobturator Helical Introducer, Right Caldera Medical Transobturator Large Helical Introducer, Left Caldera Medical Transobturator Large Helical Introducer, Right Caldera Medical Transobturator Inside-Out Introducer, Left

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

K172614 · Caldera Medical, Inc. · Gastroenterology & Urology device
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May 2018
Decision
246d
Days
Class 2
Risk

K172614 is an FDA 510(k) clearance for the Caldera Medical Transobturator Helical Introducer, Left. Classified as Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (product code PWJ), Class II - Special Controls.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on May 4, 2018 after a review of 246 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.4910 - 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 Caldera Medical, Inc. devices

Submission Details

510(k) Number K172614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2017
Decision Date May 04, 2018
Days to Decision 246 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 130d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4910
Definition Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence
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.