BiliWrap— 510(k) K243372

Substantially Equivalent

Gerium Medical, Ltd.

FDA 510(k) clearance K243372 for BiliWrap, Substantially Equivalent on 2025-05-29. Applicant: Gerium Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Gerium Medical, Ltd.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2024-10-30
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yavne, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05
K182178 — neoBLUE blanket LED Phototherapy System2018-12-13

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