MULTI-SNARE SET— 510(k) K011783

Name: FDA 510(k) clearance K011783
Creator: U.S. Food and Drug Administration
Published: 2002-01-24

Substantially Equivalent

Pfm Produkte Fur Die Medizin AG

FDA 510(k) clearance K011783 for MULTI-SNARE SET, Substantially Equivalent on 2002-01-24. Applicant: Pfm Produkte Fur Die Medizin AG. Device class: 2.

Clearance details

Applicant: Pfm Produkte Fur Die Medizin AG
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2001-06-07
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trabuco Canyon, CA, US

Download summary PDF View on FDA.gov ↗

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K002471 — JETCAN HUBER NEEEDLE SET2000-10-19
K001716 — REDON SET2000-07-19

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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 →

Recalls naming K011783

K-number listed on FDA's recall record

Z-2526-2026 — Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310Class II·Ongoing·PFM MEDICAL INC.·20260421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011783.

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