Company ยท US
American Cystocope Makers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1983. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| FAK | Panendoscope (Gastroduodenoscope) | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FEH | Electrode, Flexible Suction Coagulator | 1 |
| FGA | Kit, Nephroscope | 1 |
| FOG | Hood, Oxygen, Infant | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| LJH | System, Irrigation, Urological | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 1983 | K832040 | STERILE FLUID PRODUCING UNIT #EP550 American Cystocope Makers, Inc. | LJH |
| Oct 26, 1981 | K812637 | ACMI BIPOLAR HEMOSTATIC SOURCE American Cystocope Makers, Inc. | GEI |
| Jul 1, 1981 | K811218 | ACMI ASPIRATOR KIT #8808 American Cystocope Makers, Inc. | EOQ |
| Jan 15, 1981 | K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE American Cystocope Makers, Inc. | FEH |
| Jul 30, 1979 | K791182 | ACMI RIGI-FLEX NEPHORSCOPE American Cystocope Makers, Inc. | FGA |
| Apr 28, 1977 | K770754 | DUODENOSCOPE, MOLEL TX-6 American Cystocope Makers, Inc. | FOG |
| Oct 21, 1976 | K760822 | MODEL TX-8 PANENDOSCOPE American Cystocope Makers, Inc. | FAK |
| Aug 30, 1976 | K760452 | COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) American Cystocope Makers, Inc. | FDF |
| Aug 30, 1976 | K760451 | AIR WATER SOURCE (ACMI MODEL 710) American Cystocope Makers, Inc. | OCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||