PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID— 510(k) K943835

Name: FDA 510(k) clearance K943835
Creator: U.S. Food and Drug Administration
Published: 1995-01-24

Substantially Equivalent

Orion Life Systems, Inc.

FDA 510(k) clearance K943835 for PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID, Substantially Equivalent on 1995-01-24. Applicant: Orion Life Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orion Life Systems, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-05
Decision date: 1995-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNY

view all

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 Orion Life Systems, Inc.

view all

K943828 — STERILE WATER FOR IRRIGATION1994-11-21
K943829 — PRE-FILLED SYSRINGE W/STERILE WATER1994-11-21
K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION1994-11-21
K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER1994-11-21
K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION1994-11-21

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