510(k) Report

FDA applicant

Gallini Medical Devices, Srl

South Euclid, OH1 decision2014–20143 recalls

FDA records 1 decision for Gallini Medical Devices, Srl (South Euclid, OH) in 2014: 1 510(k) clearance. All are in product code HRX (Arthroscope). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Gallini Medical Devices, Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

3in 2021

2021: 3
2014high 3 (2021) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Gallini Medical Devices, Srl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141557Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - LumbarGallini Medical Devices, Srl · 20141cites it

What has FDA decided for it lately?

  • K141557Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - LumbarGallini Medical Devices, Srl · 20143 recalls

The one decision as Gallini Medical Devices, Srl →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K141557Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749May 17, 2021Class II
  • K141557Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745May 17, 2021Class II
  • K141557Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715May 17, 2021Class II

Other applicant names beginning “Gallini”

FDA records each applicant name separately; these may or may not be the same firm.

Gallini U.S., LLC 10Gallini Intl., Inc. 7Gallini S.R.L. 1