KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER— 510(k) K973546

Clearance details

Applicant

Kendall Healthcare Products Co. Div.Of Tyco Health

Product code

Code EZD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

1997-09-18

Decision date

1997-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mansfield, MA, US

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• K253295 — Coude Sleeved IC; Coude Plus Sleeved IC2026-05-18

• K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
• K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
• K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
• K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
• K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

Injury

864

Malfunction

2,210

Total

3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →