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Eris Uro-Diagnostic System

by Eris Medical Technology 510(k)

Active United States

510(k) K850169

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850169 Date22 Apr 1985ClearedStatusActive

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  • Withdrawn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
FFG
Device Class
Class II
Regulation
21 CFR Part 876.1800
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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