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Millereisen Curved Biopsy Needle

by Preventive Medicine Institute

510(k) K840157

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 NumberK840157 Date12 Mar 1984ClearedStatusActive

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  • Withdrawn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
FCG
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
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 Miller Eisen Curved Biopsy Needle is a biopsy needle device used for obtaining tissue samples. It is classified under the medical specialties of gastroenterology and urology.

This device received FDA 510(k) clearance under K840157 with a substantially equivalent decision on March 12, 1984. It is regulated under regulation number 876.1075 and has product code FCG. The device is intended for use in clinical settings where biopsy procedures are performed.

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 Miller Eisen Curved Biopsy Needle used for?

    The Miller Eisen Curved Biopsy Needle is used for obtaining tissue samples in clinical settings, specifically in gastroenterology and urology procedures where biopsy sampling is required.

  • How is the Miller Eisen Curved Biopsy Needle supplied or regulated?

    The device is supplied as a biopsy needle and is regulated under FDA regulation number 876.1075 with product code FCG, having received traditional 510(k) clearance based on substantial equivalence to a predicate device.

  • What is the regulatory status and clearance details for the Miller Eisen Curved Biopsy Needle?

    The Miller Eisen Curved Biopsy Needle received FDA 510(k) clearance under K840157 with a substantially equivalent decision on March 12, 1984, following a traditional review process, and is classified as a Class II device under product code FCG.