Chrysalis Intelligence · Sponsors · Torax Medical, Inc.

Torax Medical, Inc.

Shoreview, MN, US · 2 510(k) clearances · 13 PMAs

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Total clearances
2
2020-07-09 → 2023-02-09
Last 12 months
0
Product codes
1
Most recent
2023-02-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QJN — — — 2 2023-02-09
Class III

PMA approvals (13)

Total PMA records
13
Originals + supplements
Distinct product codes
1
First decision
2020-06-29
Most recent
2026-01-16
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-01-16 P100049-S041 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2026-01-16 P100049-S040 LINX™ Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2025-10-08 P100049-S038 LINX Reflux Management System Normal 180 Day Track No User Fee LEI Implant, Anti-Gastroesophageal Reflux Unknown
2024-02-22 P100049-S037 LINX Reflux Management System Normal 180 Day Track LEI Implant, Anti-Gastroesophageal Reflux Unknown
2023-12-19 P100049-S036 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2023-12-14 P100049-S035 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-10-04 P100049-S033 LINX Reflux Management System Normal 180 Day Track LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-08-26 P100049-S029 LINX Reflux Management System 135 Review Track For 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-06-09 P100049-S034 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-01-07 P100049-S032 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-01-07 P100049-S031 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2022-01-07 P100049-S030 LINX Reflux Management System 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
2020-06-29 P100049-S027 LINX Reflux Management System 135 Review Track For 30-Day Notice LEI Implant, Anti-Gastroesophageal Reflux Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-02-09 K230089 ETHICON LINX® Esophagus Sizing Tool QJN — —
2020-07-09 K201035 ETHICON Linx Esophagus Sizing Tool QJN — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence