Cleared Traditional

K863615 - ENTHERMO IRRIGATION UNIT

K863615 is an FDA 510(k) clearance for ENTHERMO IRRIGATION UNIT, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ear, Nose, Throat device with product code ETP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K863615 · Jedmed Instrument Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
91d
Days
Class 1
Risk

K863615 is an FDA 510(k) clearance for the ENTHERMO IRRIGATION UNIT. Classified as Stimulator, Caloric-water (product code ETP), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1800 - 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 Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K863615

510(k) Number K863615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date December 16, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 90d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

ETP Device Classification - Class 1, General Controls

Product Code ETP Stimulator, Caloric-water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.1800
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.