510(k) Report

FDA applicant

Glenveigh Surgical, LLC

Swanee, GA2 decisions2010–20100 recalls

FDA records 2 decisions for Glenveigh Surgical, LLC (Swanee, GA) in 2010: 2 510(k) clearances. Most are in product codes KNA (Instrument, Manual, Specialized…) and OQY (Intrauterine Tamponade Balloon). Its devices cite 5 predicates, 0 of them its own earlier devices. No 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Glenveigh Surgical, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glenveigh Surgical, LLC’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?

  • KNAInstrument, Manual, Specialized Obstetric-Gynecologic1decision
  • OQYIntrauterine Tamponade Balloon1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 20101cites it

What has FDA decided for it lately?

  • K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
  • K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010

All 2 as Glenveigh Surgical, LLC →