Solos Endoscopy, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Solos Endoscopy, Inc.” (first 1990, latest 1998), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GEN | Forceps, General & Plastic Surgery | 4 | 4 |
| GEJ | Carrier, Ligature | 2 | 2 |
| LRW | Scissors, General, Surgical | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Solos Endoscopy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983538 | MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY | GCJ | 1998-11-06 | 28 |
| K910671 | MODEL GS-4700 COMMON DUCT STONE REMOVING KIT | FGE | 1991-05-10 | 84 |
| K900965 | GS-4550 TROCAR ONLY, 11MM | FBM | 1990-04-18 | 50 |
| K900964 | CANNULA AND TROCAR, 11MM | FBM | 1990-04-18 | 50 |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | FBM | 1990-04-18 | 50 |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | FBM | 1990-04-18 | 50 |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | FBM | 1990-04-18 | 50 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | GEN | 1990-04-18 | 50 |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | GEJ | 1990-04-18 | 50 |
| K900958 | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM | GEJ | 1990-04-18 | 50 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Solos Endoscopy, 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.
- Solos Ophthalmology (5 510(k)s)
- Solos Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solos Endoscopy, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Solos Endoscopy, Inc.” (first 1990, latest 1998), across 8 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 Solos Endoscopy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solos Endoscopy, Inc. is 50 days.
Which FDA product codes appear under Solos Endoscopy, Inc.?
The most frequent FDA product codes under this applicant name are FBM (Cannula And Trocar, Suprapubic, Non-Disposable, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GEN (Forceps, General & Plastic Surgery, 4).
Next steps
- See all 21 Solos Endoscopy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FBM, Solos Endoscopy, 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.