VISI-FLOW IRRIGATOR— 510(k) K832299

Name: FDA 510(k) clearance K832299
Creator: U.S. Food and Drug Administration
Published: 1983-08-26

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K832299 for VISI-FLOW IRRIGATOR, Substantially Equivalent on 1983-08-26. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 2.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code EXD
Device class: Class 2
Regulation: 21 CFR 876.5895
Advisory panel: Gastroenterology, Urology
Date received: 1983-07-13
Decision date: 1983-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXD

view all

K121833 — OSTOMY IRRIGATION SET2012-07-16
K914692 — URINARY DIVERSION EVACUATING CATHETER1992-07-02
K904586 — PALEX IRRIGATION SET1990-12-28
K871791 — BLOXOM IRRIGATOR1987-05-20
K840268 — IRRIGATION SYSTEM1984-04-05

More clearances from Convatec, A Division of E.R. Squibb & Sons

view all

K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING2002-06-21
K990964 — SIGNADRESS DUODERM DRESSING1999-05-18
K984388 — HA ABSORBENT WOUND DRESSING1999-03-03
K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09

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