510(k) Report

FDA applicant

Novasys Medical, Inc.

Sunnyvale, CA5 decisions2000–20041 recall

FDA records 5 decisions for Novasys Medical, Inc. (Sunnyvale, CA) from 2000 to 2004: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and NVJ (Applicator, Transurethral, Radio Frequency…). Its devices cite 3 predicates, 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Novasys Medical, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Novasys Medical, Inc.’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women1decision
  • FECObturator, For Endoscope1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001150Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter…Novasys Medical, Inc. · 20001cites it
  • K013730Ariel Radio Frequency (RF) Electrosurgical Control Module and AccessoriesNovasys Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 20041 recall
  • K013730Ariel Radio Frequency (RF) Electrosurgical Control Module and AccessoriesNovasys Medical, Inc. · 2002
  • K001328Introducer SheathNovasys Medical, Inc. · 2000
  • K001150Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter…Novasys Medical, Inc. · 2000
  • K001151Electrosurgical Electrode FamilyNovasys Medical, Inc. · 2000

All 5 as Novasys Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042132Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CAJul 27, 2009