510(k) Report

FDA applicant

Cosman Medical, Inc.

Burlington, MA6 decisions2005–20103 recalls

FDA records 6 decisions for Cosman Medical, Inc. (Burlington, MA) from 2005 to 2010: 6 510(k) clearances. Most are in product codes GXI (Probe, Radiofrequency Lesion) and IYE (Accelerator, Linear, Medical). Its devices cite 23 predicates, 6 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, neurology panel, where it files most

How often FDA has decided Cosman Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 22010: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2017: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cosman Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cosman Medical, Inc.’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

Which product codes does it file in?

  • GXIProbe, Radiofrequency Lesion4decisions
  • IYEAccelerator, Linear, Medical1decision
  • GXDGenerator, Lesion, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 23 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 6 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.

  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal…Cosman Medical, Inc. · 20056cite it
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 20065cite it
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 20083cite it
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 20061cites it
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K101131Fiducial MarkersCosman Medical, Inc. · 2010
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  • K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
  • K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
  • K053415Lesionpoint RF CannulaCosman Medical, Inc. · 2006
  • K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal…Cosman Medical, Inc. · 20053 recalls

All 6 as Cosman Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K050084Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm…Apr 29, 2026Class II
  • K050084Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x…Apr 29, 2026Class II
  • K050084Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*…Jul 5, 2017Class II