Everest Medical Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Everest Medical Corp.” (first 1987, latest 2000), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 79 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 | 11 | 11 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 4 | 4 |
| FDI | Snare, Flexible | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- General and Plastic Surgery (12)
- Gastroenterology and Urology (7)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
Most recent Everest Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003060 | PLASMAKINETIC GENERATOR | GEI | 2000-10-31 | 29 |
| K000496 | EVERSHEARS BIPOLAR SCISSORS | GEI | 2000-04-24 | 69 |
| K993412 | BITX PROBES | GEI | 2000-03-31 | 171 |
| K994336 | BITX PROBES | GEI | 2000-02-08 | 47 |
| K971565 | BICOAG COAGULATING FORCEPS | HIN | 1998-03-12 | 317 |
| K955001 | EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS | GEI | 1995-12-13 | 41 |
| K945975 | EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS | GEI | 1994-12-21 | 13 |
| K922509 | LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA | GEI | 1992-10-01 | 127 |
| K922246 | TUBING SET W/ IRRIGATION & ASPIRATION VALVING | GCJ | 1992-09-02 | 112 |
| K920089 | MONOPOLAR COAGULATING POLYPECTOMY SNARE | KNS | 1992-03-31 | 83 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Everest Medical Corp..
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.
- Everest & Jennings, Inc. (30 510(k)s)
- Everest Biomedical Instruments Co. (2 510(k)s)
- Everest Interscience, Inc. (1 510(k)s)
- Everest Spine, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Everest Medical Corp.?
FDA lists 21 510(k) clearances under the applicant name “Everest Medical Corp.” (first 1987, latest 2000), across 8 product codes in 4 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 Everest Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Everest Medical Corp. is 79 days.
Which FDA product codes appear under Everest Medical Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 11); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 4); FDI (Snare, Flexible, 1).
Next steps
- See all 21 Everest Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Everest Medical Corp.'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.