Cleared Traditional

LAPAROMED LIGATING LOOP (K921053) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K921053 · Laparomed Corp. · Ear, Nose, Throat device
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Aug 1992
Decision
154d
Days
Class 1
Risk

K921053 is an FDA 510(k) clearance for the LAPAROMED LIGATING LOOP. Classified as Applicator, Ent (product code KCJ), Class I - General Controls.

Submitted by Laparomed Corp. (Irvine, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 154 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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 Laparomed Corp. devices

Submission Details

510(k) Number K921053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date August 06, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 89d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCJ Applicator, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.