Cleared Traditional

K844775 - EFFNER-EYE CAUTERY WITH BATTERY HANDLE (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844775 · Mecron Medical Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
245d
Days
Class 2
Risk

K844775 is an FDA 510(k) clearance for the EFFNER-EYE CAUTERY WITH BATTERY HANDLE. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Mecron Medical Products, Inc. (Port Washington, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 245 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Mecron Medical Products, Inc. devices

Submission Details

510(k) Number K844775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date August 12, 1985
Days to Decision 245 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 110d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQO Unit, Cautery, Thermal, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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.