FDA applicant

Quantum Surgical Sas

Montpellier, FR2 decisions2022–20232 recalls

FDA records 2 decisions for Quantum Surgical Sas (Montpellier, FR) from 2022 to 2023: 2 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 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, radiology panel, where it files most

How often FDA has decided Quantum Surgical Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022high 1 (2024) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Quantum Surgical Sas by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quantum Surgical Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Quantum”

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

Quantum Orthopedics, Inc. 6 Quantum Medical Imaging, LLC 5 Quantum Medical Systems, Inc. 5 Quantum Bioengineering, Ltd. 4 Quantum Co., Ltd. 3 Quantum Medical Concepts, LLC 2 Quantum Instruments Corp. 2 Quantum Devices, Inc. 2 Quantum Skincare, Inc. 1 Quantum Intl. 1 Quantum Medical Imaging Divison of Carestream 1 Quantum Life Systems, Inc. 1

Quantum Surgical Sas

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Quantum”