Cleared Traditional

14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE (K122263) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122263 · Symmetry Medical · General Hospital
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Sep 2012
Decision
63d
Days
Class 2
Risk

K122263 is an FDA 510(k) clearance for the 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE. Classified as Tunneled Catheter Remover (product code ODY), Class II - Special Controls.

Submitted by Symmetry Medical (Antioch, US). The FDA issued a Cleared decision on September 28, 2012 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Symmetry Medical devices

Submission Details

510(k) Number K122263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date September 28, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODY Tunneled Catheter Remover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
Definition To Assist In The Removal Of Tunneled Long Term Catheter Cuffs Using A Minimal Invasive Technique By Seperating The Tissue Ingrowth Cuff From The Surrounding Tissue. Following Seperation Of The Cuff From The Tissue, The Catheter Can Be Safely Removed From The Body.
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 General Hospital devices follow this clearance model.