Cleared Traditional

K921053 - LAPAROMED LIGATING LOOP

K921053 is an FDA 510(k) clearance for LAPAROMED LIGATING LOOP, manufactured by Laparomed Corp.. The device is a Class 1 Ear, Nose, Throat device with product code KCJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K921053

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.

KCJ Device Classification - Class 1, General Controls

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.