510(k) Report

FDA applicant

Sanarus Medical, Inc.

Pleasanton, CA14 decisions2002–20082 recalls

FDA records 14 decisions for Sanarus Medical, Inc. (Pleasanton, CA) from 2002 to 2008: 14 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and KNW (Instrument, Biopsy). Its devices cite 14 predicates, 11 of them its own earlier devices. 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sanarus Medical, Inc.’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?

  • GEHUnit, Cryosurgical, Accessories7decisions
  • KNWInstrument, Biopsy6decisions
  • FZPClip, Implantable1decision

Whose devices does it build on?

Its devices cite 14 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 11 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.

  • K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 20053cite it
  • K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 20022cite it
  • K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 20042cite it
  • K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 20021cites it
  • K020605Sanarus Visica Treatment SystemSanarus Medical, Inc. · 20021cites it
  • K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 20031cites it

What has FDA decided for it lately?

  • K080171Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc. · 2008
  • K073533Sanarus V2 Treatment SystemSanarus Medical, Inc. · 2008
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  • K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
  • K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
  • K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003

All 14 as Sanarus Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K022314Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)Jun 16, 2003
  • K022879Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code…May 13, 2003