510(k) Report

FDA applicant

Aragon Surgical, Inc.

Palo Alto, CA6 decisions2007–20112 recalls

FDA records 6 decisions for Aragon Surgical, Inc. (Palo Alto, CA) from 2007 to 2011: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HIF (Insufflator, Laparoscopic). Its devices cite 14 predicates, 4 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 Aragon Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12008: 22009: 12010: 12011: 1
2007high 2 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Aragon Surgical, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • HIFInsufflator, Laparoscopic2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 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.

  • K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 20093cite it
  • K070651Aragon Surgical LapcapAragon Surgical, Inc. · 20072cite it
  • K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 20081cites it
  • K081312Aragon Oneshot SystemAragon Surgical, Inc. · 20081cites it
  • K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 20101cites it
  • K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 20111cites it

What has FDA decided for it lately?

  • K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc. · 2011
  • K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc. · 20102 recalls
  • K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc. · 2009
  • K081312Aragon Oneshot SystemAragon Surgical, Inc. · 2008
  • K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
  • K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007

All 6 as Aragon Surgical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K093075CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended…Aug 7, 2019Class II
  • K093075CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended…Aug 7, 2019Class II