510(k) Report

FDA applicant

Ntero Surgical, Inc.

Palo Alto, CA3 decisions1999–20020 recalls

FDA records 3 decisions for Ntero Surgical, Inc. (Palo Alto, CA) from 1999 to 2002: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 predicates, 1 of them its own earlier devices. No 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 Ntero Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ntero Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ntero 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 & Accessories3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 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.

  • K992572Ntero RF SleeveNtero Surgical, Inc. · 19991cites it

What has FDA decided for it lately?

  • K014251Ntero Hotrod SystemNtero Surgical, Inc. · 2002
  • K010815Ntero Nomad SystemNtero Surgical, Inc. · 2001
  • K992572Ntero RF SleeveNtero Surgical, Inc. · 1999

All 3 as Ntero Surgical, Inc. →