American Endoscopy, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “American Endoscopy, Inc.” (first 1982, latest 1985), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 53 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FFT | Electrode, Ph, Stomach | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GCP | Endoscope, Ac-Powered And Accessories | 1 | 1 |
| GEE | Brush, Biopsy, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNQ | Dilator, Esophageal | 1 | 1 |
Plus 6 more product codes.
Review panels
- Gastroenterology and Urology (14)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent American Endoscopy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853274 | AMERICAN DILATATION SYSTEM | KNQ | 1985-10-17 | 73 |
| K841384 | PROXIMA 1 PH MONITOR | FFT | 1984-07-19 | 121 |
| K833491 | ENDO BITE BLOCK | KTI | 1984-04-25 | 201 |
| K840818 | BIOPSY FORCEPS | FCL | 1984-04-13 | 49 |
| K833859 | TAMPONADE BALLOON CUFF | GCP | 1984-01-03 | 57 |
| K833492 | PERCUTANEOUS ENDOSCOPIC GASTROSCOPY | KNT | 1983-11-29 | 53 |
| K832458 | AUTOMATIC ENDOSCOPE | NVE | 1983-10-20 | 86 |
| K821818 | RETRIEVAL BALLOONS | KOD | 1982-09-24 | 95 |
| K821819 | PIGTAIL STENTS | FGE | 1982-08-20 | 60 |
| K822062 | BALL TIP COAGULATING ELECTRODES | GEI | 1982-08-19 | 37 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American 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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Endoscopy, Inc.?
FDA lists 19 510(k) clearances under the applicant name “American Endoscopy, Inc.” (first 1982, latest 1985), across 16 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 American Endoscopy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Endoscopy, Inc. is 53 days.
Which FDA product codes appear under American Endoscopy, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 2); KOD (Catheter, Urological, 2).
Next steps
- See all 19 American Endoscopy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, American 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.