CURITY THORACENTESIS TRAY— 510(k) K964519

Name: FDA 510(k) clearance K964519
Creator: U.S. Food and Drug Administration
Published: 1996-12-20

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K964519 for CURITY THORACENTESIS TRAY, Substantially Equivalent on 1996-12-20. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 2.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1996-11-12
Decision date: 1996-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K972074 — SUCTION INSTRUMENTATION1997-07-25
K971022 — CHASE SUCKER1997-04-17
K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

More clearances from Kendall Healthcare Products Co. Div.Of Tyco Health

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K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

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.