Cleared Traditional

K172737 - MESIRE - Balloon Sinus Dilatation System (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K172737 · M/S. Meril Life Sciences Private Limited · Ear, Nose, Throat device
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Dec 2017
Decision
92d
Days
Class 1
Risk

K172737 is an FDA 510(k) clearance for the MESIRE - Balloon Sinus Dilatation System. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by M/S. Meril Life Sciences Private Limited (Chala, Vapi, IN). The FDA issued a Cleared decision on December 12, 2017 after a review of 92 days - within the typical 510(k) review window.

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 M/S. Meril Life Sciences Private Limited devices

Submission Details

510(k) Number K172737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2017
Decision Date December 12, 2017
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
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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