DeviceClearance

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM— 510(k) K123553

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K123553 for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM, Substantially Equivalent on 2013-08-09. Applicant: Zimmer, Inc.. Device class: 1.

Clearance details

Applicant
Zimmer, Inc.
Product code
Product code KCY
Device class
Class 1
Regulation
21 CFR 878.5910
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianpolis, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KCY

product code KCY
Malfunction
868
Total
868

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K123553

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123553.

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