PRO PULSE SYRINGE IRRIGATION SYSTEM— 510(k) K941385

Name: FDA 510(k) clearance K941385
Creator: U.S. Food and Drug Administration
Published: 1994-06-09

Substantially Equivalent

Giesy Consultants, Inc.

FDA 510(k) clearance K941385 for PRO PULSE SYRINGE IRRIGATION SYSTEM, Substantially Equivalent on 1994-06-09. Applicant: Giesy Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Giesy Consultants, Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-22
Decision date: 1994-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJH

view all

K254111 — Irrigation/Urology Sets2026-09-10
K162992 — Karl Storz UROMAT E.A.S.I.2017-07-07
K070873 — AMSURE BLADDER IRRIGATION SET2007-12-19
K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM2007-09-18
K063700 — SPYGLASS IRRIGATION SYSTEM2007-02-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.