Cleared Traditional

K802332 - INTRAJECT

K802332 is an FDA 510(k) clearance for INTRAJECT, manufactured by General Medical Engineering Corp.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K802332 · General Medical Engineering Corp. · Ophthalmic device
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Dec 1980
Decision
90d
Days
Class 1
Risk

K802332 is an FDA 510(k) clearance for the INTRAJECT. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by General Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K802332

510(k) Number K802332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date December 22, 1980
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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 - KYG Device, Irrigation, Ocular Surgery

All 39
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K802332.
LENS
K821897 · Mortan, Inc. · Jan 1983
ASPIRATOR/IRRIGATOR OR I/A UNIT
K820889 · Mid Laboratories, Inc. · May 1982
DISPOSABLE TUBING SETS
K820680 · Innovative Surgical Products, Inc. · Apr 1982
NU-VISION DISP. OPHTHALMIC DRESSING TRAY
K801822 · Summit Optics, Inc. · Sep 1980
NALGENE EMERGENCY EYE WASH
K760820 · Nagle Co. · Oct 1976
K802332 · INTRAJECT
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