Symbiosis Corp.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Symbiosis Corp.” (first 1989, latest 1996), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 114 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 | 5 | 5 |
| GAA | Needle, Aspiration And Injection, Disposable | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FCL | Forceps, Biopsy, Non-Electric | 3 | 3 |
| GBX | Catheter, Irrigation | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| KGE | Forceps, Biopsy, Electric | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| FHP | Needle, Pneumoperitoneum, Simple | 1 | 1 |
Plus 9 more product codes.
Review panels
- General and Plastic Surgery (18)
- Gastroenterology and Urology (8)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (2)
- Orthopedic (2)
- Microbiology (1)
Most recent Symbiosis Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955119 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | HIH | 1996-01-18 | 70 |
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | FAS | 1996-01-17 | 182 |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | KNF | 1995-10-06 | 87 |
| K952432 | SYMBIOSIS BIPOLAR FORCEPS | GEI | 1995-07-05 | 42 |
| K951387 | SYMBIOSIS BIPOLAR SCISSORS | GCJ | 1995-04-10 | 14 |
| K950286 | SYMBIOSIS BIPOLAR SCISSORS | GCJ | 1995-02-03 | 10 |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | FCL | 1995-01-20 | 29 |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | HFB | 1994-07-28 | 527 |
| K941426 | SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE | GEI | 1994-06-22 | 90 |
| K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN | KGE | 1994-03-15 | 329 |
24 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2002-11-27.
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 Symbiosis Corp.?
FDA lists 34 510(k) clearances under the applicant name “Symbiosis Corp.” (first 1989, latest 1996), across 19 product codes in 6 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 Symbiosis Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Symbiosis Corp. is 114 days.
Which FDA product codes appear under Symbiosis Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); GAA (Needle, Aspiration And Injection, Disposable, 4); GCJ (Laparoscope, General & Plastic Surgery, 4).
Next steps
- See all 34 Symbiosis Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Symbiosis 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, 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.