Cleared Traditional

K130736 - BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K130736 · Helix Medical, LLC · Ear, Nose, Throat device
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Dec 2013
Decision
274d
Days
Class 1
Risk

K130736 is an FDA 510(k) clearance for the BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on December 17, 2013 after a review of 274 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Helix Medical, LLC devices

Submission Details

510(k) Number K130736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date December 17, 2013
Days to Decision 274 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 89d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 64
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