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After Loading Buchler

by Ellis Pharmaceutical Consulting, Inc.

510(k) K832789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832789 Date29 Sep 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The After Loading Buchler is a remote-controlled radionuclide system and applicator used in radiology. It is classified as a Class II medical device under regulation number 892.5700 with product code JAQ.

It received FDA 510(k) clearance (K832789) through a traditional submission process on September 29, 1983, and is manufactured by Ellis Pharmaceutical Consulting, Inc. The device is substantially equivalent to a legally marketed predicate device.

Other devices from Ellis Pharmaceutical Consulting, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the After Loading Buchler used for?

    The After Loading Buchler is a remote-controlled radionuclide system and applicator used in radiology for delivering radioactive sources to treatment sites, allowing clinicians to administer brachytherapy from a safe distance.

  • How is the After Loading Buchler supplied and is it reusable?

    The device is supplied as a remote-controlled system and applicator designed for repeated use in clinical settings; it is not a single-use item but requires proper maintenance and quality checks between procedures to ensure safe operation.

  • What regulatory pathway was used for the After Loading Buchler?

    The After Loading Buchler received FDA 510(k) clearance through a traditional submission process on September 29, 1983, under K832789, demonstrating substantial equivalence to a legally marketed predicate device.