Cleared Traditional

K945877 - WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTI...

K945877 is an FDA 510(k) clearance for WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTI..., manufactured by Wells Johnson Co.. The device is a Class 2 Ophthalmic device with product code HJM cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K945877 · Wells Johnson Co. · Ophthalmic device
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Mar 1995
Decision
91d
Days
Class 2
Risk

K945877 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - 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.

View all Wells Johnson Co. devices

FDA 510(k) Submission Details - K945877

510(k) Number K945877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date March 02, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJM Device Classification - Class 2, Special Controls

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.