Oratec Interventions, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Oratec Interventions, Inc.” (first 1995, latest 2002), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 21 | 21 |
| HRX | Arthroscope | 3 | 3 |
Review panels
Most recent Oratec Interventions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013622 | NUCLEOTOMY INTRADISCAL CATHETER | GEI | 2002-01-31 | 87 |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | HRX | 2001-08-29 | 321 |
| K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | HRX | 2001-03-01 | 73 |
| K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | HRX | 2000-05-04 | 65 |
| K992805 | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) | GEI | 2000-02-04 | 168 |
| K994333 | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES | GEI | 2000-01-18 | 26 |
| K993967 | ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 | GEI | 1999-12-17 | 24 |
| K993854 | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | GEI | 1999-12-06 | 21 |
| K991140 | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES | GEI | 1999-10-25 | 203 |
| K991218 | ORATEC BIPOLAR ABLATION PROBES | GEI | 1999-09-13 | 154 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oratec Interventions, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Oratec Dental Products (3 510(k)s)
- Oratec Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oratec Interventions, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Oratec Interventions, Inc.” (first 1995, latest 2002), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oratec Interventions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oratec Interventions, Inc. is 76 days.
Which FDA product codes appear under Oratec Interventions, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 21); HRX (Arthroscope, 3).
Next steps
- See all 24 Oratec Interventions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Oratec Interventions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.