510(k) Report

FDA applicant

Urologix, Inc.

Plymouth3 decisions1996–20155 recalls

FDA records 3 decisions for Urologix, Inc. (Plymouth) from 1996 to 2015: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes MEQ (System, Hyperthermia, Rf/Microwave (Benign…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Urologix, LLC”.

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 Urologix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2007: 22010: 12011: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Urologix, 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?

  • MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode…Urologix, Inc. · 20151cites it

What has FDA decided for it lately?

  • K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode…Urologix, Inc. · 2015
  • P970008Targis (T3) SystemUrologix, LLC · 19974 recalls
  • P950014ProstatronUrologix, Inc. · 19961 recall

All 2 as Urologix, Inc. →The one decision as Urologix, LLC →

What has been recalled?

5 recalls linked to its devices; the latest:

  • P970008The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured…Apr 28, 2011
  • P970008UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long…Feb 18, 2010
  • P970008Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of…Mar 16, 2007
  • P970008Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of…Mar 16, 2007
  • P950014Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is…Dec 10, 2003