510(k) Report

FDA applicant

Uromed Corp.

Needham, MA11 decisions1996–20011 recall

FDA records 11 decisions for Uromed Corp. (Needham, MA) from 1996 to 2001: 10 510(k) clearances and 1 original PMA approval. Most are in product codes ETN (Stimulator, Nerve) and FGM (Probe And Director, Gastro-Urology). Its devices cite 13 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Uromed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uromed Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • ETNStimulator, Nerve3decisions
  • FGMProbe And Director, Gastro-Urology2decisions
  • KXKSource, Brachytherapy, Radionuclide1decision
  • MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1decision
  • FHAClamp, Penile1decision
  • KNAInstrument, Manual, Specialized Obstetric-Gynecologic1decision

Also: OCW (1), OCK (1).

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 19993cite it
  • K974600Uromed PatchUromed Corp. · 19981cites it
  • K993436Cavermap Surgical AidUromed Corp. · 20001cites it
  • K970971Uro Med Nerve StimulatorUromed Corp. · 19971cites it

What has FDA decided for it lately?

  • K010213Modification to Cavermap Surgical AidUromed Corp. · 2001
  • K010098Modification to Cavermap Surgical AidUromed Corp. · 2001
  • K000507Cavermap Surgical AidUromed Corp. · 20001 recall
  • K993436Cavermap Surgical AidUromed Corp. · 20001 recall
  • K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
  • K980717Uromed Sling KitUromed Corp. · 1998
  • K974600Uromed PatchUromed Corp. · 1998
  • K974137Uromed Needle GrasperUromed Corp. · 1998

All 11 as Uromed Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K993436CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305Jul 10, 2003