510(k) Report

FDA applicant

Starion Instruments

Saratoga, CA13 decisions1999–20073 recalls

FDA records 13 decisions for Starion Instruments (Saratoga, CA) from 1999 to 2007: 13 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HQP (Unit, Cautery, Thermal, Battery-Powered). Its devices cite 7 predicates, 6 of them its own earlier devices. 3 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2019

2008: 12010: 12019: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Starion Instruments’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • HQPUnit, Cautery, Thermal, Battery-Powered3decisions
  • HQOUnit, Cautery, Thermal, Ac-Powered3decisions
  • HQRApparatus, Cautery, Radiofrequency, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 7 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K990728Thermal Cautery Device, ForcepsStarion Instruments · 19992cite it
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 20042cite it
  • K062257Starion Instruments Thermal Litigating ShearsStarion Instruments · 20062cite it
  • K000296Starion Cautery HookStarion Instruments · 20001cites it
  • K000893AC Powered Thermal Cautery UnitStarion Instruments · 20001cites it
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 20001cites it

What has FDA decided for it lately?

  • K070871Starion Universal Power SupplyStarion Instruments · 2007
  • K062257Starion Instruments Thermal Litigating ShearsStarion Instruments · 20063 recalls
  • K050308Thermal Cautery ProbeStarion Instruments · 2005
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
  • K001262Thermal Cautery ForcepsStarion Instruments · 2000
  • K000893AC Powered Thermal Cautery UnitStarion Instruments · 2000
  • K001273Starion Instruments Power Point Cautery ClampStarion Instruments · 2000

All 13 as Starion Instruments →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K062257TLS2 Thermal Ligating Shears, Catalog Number 132-131DMar 22, 2019Class II
  • K062257The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers…Mar 9, 2010
  • K062257Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical…Jun 26, 2008