Fiber Imaging Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fiber Imaging Technologies, Inc.” (first 1999, latest 1999), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- Ear, Nose and Throat (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Fiber Imaging Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993300 | COLDLIGHTSOURCE PL3000 | FCW | 1999-11-05 | 35 |
| K992527 | URETERO-RENOSCOPE | FGB | 1999-10-13 | 77 |
| K992437 | SCHOELLY RIGID ENDOSCOPES | GCJ | 1999-09-14 | 54 |
| K992040 | FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES | HRX | 1999-08-06 | 50 |
| K991560 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | 1999-07-13 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Fiber Imaging Technologies, 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.
- Fiber Delivery Concepts, Inc. (4 510(k)s)
- Fiber Optics Engineering, Inc. (2 510(k)s)
- Fiber Imaging, Inc. (1 510(k)s)
- Fiber Mesh, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fiber Imaging Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Fiber Imaging Technologies, Inc.” (first 1999, latest 1999), across 5 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 Fiber Imaging Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fiber Imaging Technologies, Inc. is 54 days.
Which FDA product codes appear under Fiber Imaging Technologies, Inc.?
The most frequent FDA product codes under this applicant name are EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FCW (Light Source, Fiberoptic, Routine, 1); FGB (Ureteroscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 5 Fiber Imaging Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOB, Fiber Imaging Technologies, 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.