I.D.A. SYRINGES— 510(k) K931632

Name: FDA 510(k) clearance K931632
Creator: U.S. Food and Drug Administration
Published: 1993-08-24

Substantially Equivalent

Pt Hasoon Chandra

FDA 510(k) clearance K931632 for I.D.A. SYRINGES, Substantially Equivalent on 1993-08-24. Applicant: Pt Hasoon Chandra. Device class: 2.

Clearance details

Applicant: Pt Hasoon Chandra
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1993-04-02
Decision date: 1993-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.