URINARY DRAINAGE BAG— 510(k) K781987

Substantially Equivalent

Kelsar Corp.

FDA 510(k) clearance K781987 for URINARY DRAINAGE BAG, Substantially Equivalent on 1978-12-04. Applicant: Kelsar Corp.. Device class: 2.

Clearance details

Applicant: Kelsar Corp.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1978-11-24
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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 Kelsar Corp.

K790005 — ADMINISTRATION SET, ENEMA1979-01-17

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