Chrysalis Intelligence · Sponsors · Epimed International, Inc.

Epimed International, Inc.

Farmers Branch, TX, US · 2 510(k) clearances · 3 recalls

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Total clearances
2
2020-04-27 → 2024-05-24
Last 12 months
0
Product codes
2
Most recent
2024-05-24
Name variants in FDA filings: Epimed International / Epimed International, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GXD Generator, Lesion, Radiofrequency Class II Neurology 1 2024-05-24
BSO Catheter, Conduction, Anesthetic Class II Anesthesiology 1 2020-04-27
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-02-01
DateSeverityStatusRecall # ProductCodeReason
2021-02-01 Class II Terminated Z-1276-2021 Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidu… — Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
2020-02-21 Class II Terminated Z-1850-2020 R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Pro… — Incorrect expiration date on introduction cannula packaging.
2020-02-21 Class II Terminated Z-1849-2020 R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Pro… — Incorrect expiration date on introduction cannula packaging.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2024-05-24 K232632 Racz Neurostat RF Generator GXD Class II Neurology
2020-04-27 K200624 Percutaneous Introducer BSO Class II Anesthesiology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence