Skip to content

Prostatic Core-Cut Needle

by Euro-Med Intl. 510(k)

Active United States

510(k) K883884

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883884 Date5 Dec 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Euro-Med Intl.

  • Knife

    Class I

  • Hook Scissor

    Class I

  • Kevor-Curette

    Class II

  • Ruler

    Class I

  • Episiotomy Scissors

    Not classified

  • Hook Probe

    Class I

See all devices from Euro-Med Intl. →