510(k) Report

FDA applicant

Imagyn Surgical

Richland, MI3 decisions1999–20030 recalls

FDA records 3 decisions for Imagyn Surgical (Richland, MI) from 1999 to 2003: 3 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and DSB (Plethysmograph, Impedance). Its devices cite 7 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Imagyn Surgical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Imagyn Surgical’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?

  • KNWInstrument, Biopsy2decisions
  • DSBPlethysmograph, Impedance1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K99393615MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy…Imagyn Surgical · 19992cite it
  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 20031cites it
  • K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 20011cites it

What has FDA decided for it lately?

  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
  • K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
  • K99393615MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy…Imagyn Surgical · 1999

All 3 as Imagyn Surgical →

Other applicant names beginning “Imagyn”

FDA records each applicant name separately; these may or may not be the same firm.

Imagyn Medical, Inc. 19Imagyn Medical Technologies, Inc. 7