BODY-JET— 510(k) K082025

Substantially Equivalent

Human Med AG

FDA 510(k) clearance K082025 for BODY-JET, Substantially Equivalent on 2008-08-13. Applicant: Human Med AG. Device class: 2.

Clearance details

Applicant: Human Med AG
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2008-07-17
Decision date: 2008-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schwerin, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K082025

K-number listed on FDA's recall record

Z-1251-2025 — human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.Class II·Ongoing·HUMAN MED AG·20241018

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082025.

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