Cleared Traditional

K934084 - BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE

K934084 is an FDA 510(k) clearance for BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE, manufactured by Bioenterics Corp.. The device is a Class 1 Ophthalmic device with product code HMJ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K934084 · Bioenterics Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
118d
Days
Class 1
Risk

K934084 is an FDA 510(k) clearance for the BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE. Classified as Screen, Tangent, Projection, Battery-powered (product code HMJ), Class I - General Controls.

Submitted by Bioenterics Corp. (Carpinteria, US). The FDA issued a Cleared decision on December 16, 1993 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1810 - 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 Bioenterics Corp. devices

FDA 510(k) Submission Details - K934084

510(k) Number K934084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1993
Decision Date December 16, 1993
Days to Decision 118 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
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

HMJ Device Classification - Class 1, General Controls

Product Code HMJ Screen, Tangent, Projection, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1810
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.