CPR YANKAUER— 510(k) K960223

Name: FDA 510(k) clearance K960223
Creator: U.S. Food and Drug Administration
Published: 1996-03-28

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960223 for CPR YANKAUER, Substantially Equivalent on 1996-03-28. Applicant: Custom Pack Reliability. Device class: 2.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1996-01-16
Decision date: 1996-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCX

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K042454 — STRYKER CASSETTE PUMP2004-12-09
K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM1999-08-03
K972074 — SUCTION INSTRUMENTATION1997-07-25
K971022 — CHASE SUCKER1997-04-17
K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

More clearances from Custom Pack Reliability

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K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960243 — CPR C-SECTION DELIVERY PACK1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.