GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD— 510(k) K902430

Name: FDA 510(k) clearance K902430
Creator: U.S. Food and Drug Administration
Published: 1990-08-02

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K902430 for GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD, Substantially Equivalent on 1990-08-02. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 1990-05-31
Decision date: 1990-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.