Cleared Traditional

K832789 - AFTER LOADING BUCHLER

K832789 is an FDA 510(k) clearance for AFTER LOADING BUCHLER, manufactured by Ellis Pharmaceutical Consulting, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K832789 · Ellis Pharmaceutical Consulting, Inc. · Radiology device
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Sep 1983
Decision
45d
Days
Class 2
Risk

K832789 is an FDA 510(k) clearance for the AFTER LOADING BUCHLER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Ellis Pharmaceutical Consulting, Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight 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 Ellis Pharmaceutical Consulting, Inc. devices

FDA 510(k) Submission Details - K832789

510(k) Number K832789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date September 29, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 182
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K832789.
GAMMAMED 12I
K891131 · Mick Radio-Nuclear Instruments, Inc. · Aug 1989
CURIETRON
K840127 · Syncor Intl. Corp. · Mar 1984
MULTITREAT 48
K834308 · Mick Radio-Nuclear Instruments, Inc. · Jan 1984
SELECTRON REMOTE ISOTOPE
K810051 · Victoreen, Inc. · Feb 1981
GAMMA MED II
K781274 · Mick Radio-Nuclear Instruments, Inc. · Aug 1978