Gabriel Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gabriel Medical, Inc.” (first 1990, latest 1996), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 2 | 2 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Gabriel Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | FAT | 1996-06-27 | 163 |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | FCS | 1995-02-07 | 113 |
| K945297 | INFRA VISION IMAGING SYSTEM | GCJ | 1994-12-20 | 50 |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | FCS | 1994-05-02 | 119 |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | DSF | 1990-05-09 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Gabriel Medical, 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.
- Gabriel Ent. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gabriel Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Gabriel Medical, Inc.” (first 1990, latest 1996), across 4 product codes in 3 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 Gabriel Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gabriel Medical, Inc. is 113 days.
Which FDA product codes appear under Gabriel Medical, Inc.?
The most frequent FDA product codes under this applicant name are FCS (Light, Catheter, Fiberoptic, Glass, Ureteral, 2); DSF (Recorder, Paper Chart, 1); FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, 1).
Next steps
- See all 5 Gabriel Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCS, Gabriel Medical, 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.