ORION SUCTION CATHETER KIT WITH STERILE SALINE— 510(k) K942274

Name: FDA 510(k) clearance K942274
Creator: U.S. Food and Drug Administration
Published: 1994-06-02

Unknown

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K942274 for ORION SUCTION CATHETER KIT WITH STERILE SALINE, Unknown on 1994-06-02. Applicant: Regulatory & Marketing Services, Inc.. Device class: 1.

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1994-05-10
Decision date: 1994-06-02
Decision: Unknown
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBX

view all

K131659 — MOERAE VEIN PREPARATION KIT2014-03-03
K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
K043515 — GRAFTSAVER2005-03-31
K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

More clearances from Regulatory & Marketing Services, Inc.

view all

K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE1996-04-10
K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER1995-10-30
K941342 — PAIN DOC1995-10-13
K941543 — DIAL MEDICAL KIT1995-02-16
K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG1995-02-15

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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 →

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