Cleared Traditional

K840004 - WEE BAG O'MERCURY (FDA 510(k) Clearance)

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

K840004 · Surgi-Quip Inc.U · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
78d
Days
Class 2
Risk

K840004 is an FDA 510(k) clearance for the WEE BAG O'MERCURY. Classified as Applicator, Ocular Pressure (product code LCC), Class II - Special Controls.

Submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgi-Quip Inc.U devices

Submission Details

510(k) Number K840004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date March 22, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCC Applicator, Ocular Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4610
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.