FOLEY CATHETER TRAY— 510(k) K931013

Substantially Equivalent

Kit Pak, Inc.

FDA 510(k) clearance K931013 for FOLEY CATHETER TRAY, Substantially Equivalent on 1993-08-09. Applicant: Kit Pak, Inc.. Device class: 2.

Clearance details

Applicant: Kit Pak, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1993-02-26
Decision date: 1993-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNY

K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050)2026-08-05
K182144 — Bi-Flex Evo2018-09-07
K162356 — Vesair Cystoscopic Sheath2017-03-02
K140441 — BI-FLEX URETERAL ACCESS SHEATH2014-06-17
K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE2014-06-16

More clearances from Kit Pak, Inc.

K942959 — KIT PAK WET SALINE DRESSING1995-02-14
K941499 — KIT PAK DRESSING CHANGE TRAY1994-07-20
K932310 — KIT PAK INCONTINENT SKIN CARE KIT1994-06-01
K934080 — URINARY DRAINAGE BAG1994-05-18
K923905 — WOUND DRESSING KIT1993-07-02

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