O.R. Concepts, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “O.R. Concepts, Inc.” (first 1986, latest 1994), across 16 product codes in 5 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 9 | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 | 7 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| FGS | Carrier, Sponge, Endoscopic | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| GCI | Laryngoscope, Endoscope | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
| HQZ | Frame, Spectacle | 1 | 1 |
Plus 6 more product codes.
Review panels
- General and Plastic Surgery (23)
- General Hospital (3)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Ophthalmic (1)
Most recent O.R. Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | GEI | 1994-08-17 | 149 |
| K935971 | FLOWGUN ELECTROCAUTERY PROBES | GEI | 1994-05-16 | 154 |
| K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE | GEI | 1994-05-16 | 154 |
| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | GCJ | 1994-03-07 | 104 |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | GEI | 1993-10-15 | 308 |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | HIF | 1993-09-24 | 499 |
| K922197 | INSUFFLATOR TUBING KIT | HIG | 1993-09-24 | 501 |
| K932449 | DR. FOG | OCT | 1993-08-11 | 83 |
| K925147 | ORC 10.0MM SUCTION PROBE | GCJ | 1993-06-25 | 255 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | GCY | 1993-05-21 | 231 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named O.R. Concepts, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under O.R. Concepts, Inc.?
FDA lists 34 510(k) clearances under the applicant name “O.R. Concepts, Inc.” (first 1986, latest 1994), across 16 product codes in 5 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 O.R. Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O.R. Concepts, Inc. is 84 days.
Which FDA product codes appear under O.R. Concepts, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 9); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 2).
Next steps
- See all 34 O.R. Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, O.R. Concepts, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.