FDA applicant

Oratec Interventions, Inc.

Menlo Park, CA24 decisions1995–20020 recalls

FDA records 24 decisions for Oratec Interventions, Inc. (Menlo Park, CA) from 1995 to 2002: 24 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HRX (Arthroscope). Its devices cite 22 predicates, 14 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 Oratec Interventions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oratec Interventions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oratec Interventions, 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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Other applicant names beginning “Oratec”

FDA records each applicant name separately; these may or may not be the same firm.

Oratec Dental Products 3 Oratec Corp. 1

Oratec Interventions, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Oratec”