American Cystocope Makers, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “American Cystocope Makers, Inc.” (first 1976, latest 1983), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FAK | Panendoscope (Gastroduodenoscope) | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FEH | Electrode, Flexible Suction Coagulator | 1 | 1 |
| FGA | Kit, Nephroscope | 1 | 1 |
| FOG | Hood, Oxygen, Infant | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
- Gastroenterology and Urology (6)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- General and Plastic Surgery (1)
Most recent American Cystocope Makers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832040 | STERILE FLUID PRODUCING UNIT #EP550 | LJH | 1983-09-29 | 97 |
| K812637 | ACMI BIPOLAR HEMOSTATIC SOURCE | GEI | 1981-10-26 | 41 |
| K811218 | ACMI ASPIRATOR KIT #8808 | EOQ | 1981-07-01 | 58 |
| K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE | FEH | 1981-01-15 | 28 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | FGA | 1979-07-30 | 35 |
| K770754 | DUODENOSCOPE, MOLEL TX-6 | FOG | 1977-04-28 | 3 |
| K760822 | MODEL TX-8 PANENDOSCOPE | FAK | 1976-10-21 | 8 |
| K760452 | COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) | FDF | 1976-08-30 | 14 |
| K760451 | AIR WATER SOURCE (ACMI MODEL 710) | OCX | 1976-08-30 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named American Cystocope Makers, 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 Cystocope Makers, Inc.?
FDA lists 9 510(k) clearances under the applicant name “American Cystocope Makers, Inc.” (first 1976, latest 1983), across 9 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 Cystocope Makers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Cystocope Makers, Inc. is 28 days.
Which FDA product codes appear under American Cystocope Makers, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 1); FAK (Panendoscope (Gastroduodenoscope), 1); FDF (Colonoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 9 American Cystocope Makers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, American Cystocope Makers, 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.