HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR— 510(k) K141557
Substantially EquivalentGallini Medical Devices, Srl
FDA 510(k) clearance K141557 for HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR, Substantially Equivalent on 2014-12-08. Applicant: Gallini Medical Devices, Srl. Device class: 2.
Clearance details
- Applicant
- Gallini Medical Devices, Srl
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Euclid, OH, US
Recent devices under product code HRX
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . 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 K141557
K-number listed on FDA's recall record- Z-0144-2022 — Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
- Z-0145-2022 — Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
- Z-0146-2022 — Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141557.
Data sourced from openFDA. This site is unofficial and independent of the FDA.