Company ยท US
Acmi Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2006. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | 4 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 |
| FBP | Telescope, Rigid, Endoscopic | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HHI | System, Abortion, Vacuum | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| KNY | Accessories, Catheter, G-U | 1 |
| OCU | Endoscopic Storage Cover | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2006 | K061975 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK Acmi Corporation | GEI |
| May 25, 2006 | K060752 | ACMI DUR-HL LASER SYSTEMS Acmi Corporation | GEX |
| Mar 31, 2006 | K060269 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM Acmi Corporation | FBN |
| Sep 2, 2005 | K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 Acmi Corporation | KNY |
| Aug 16, 2005 | K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL Acmi Corporation | FGB |
| Mar 3, 2005 | K043581 | DUAL LUMEN CATHETER Acmi Corporation | EYB |
| Nov 1, 2004 | K042069 | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM Acmi Corporation | GCJ |
| Sep 10, 2004 | K042225 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 Acmi Corporation | FAJ |
| Sep 2, 2003 | K031758 | ACMI M4 TELESCOPES Acmi Corporation | FBP |
| Jul 16, 2003 | K030960 | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE Acmi Corporation | FAJ |
| Jun 23, 2003 | K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM Acmi Corporation | HHI |
| Jun 3, 2003 | K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH Acmi Corporation | OCU |
| May 21, 2003 | K031001 | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE Acmi Corporation | FAS |
| Jan 3, 2003 | K023358 | USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 Acmi Corporation | FGB |
| Aug 22, 2002 | K022480 | ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC Acmi Corporation | HIH |
| Jul 16, 2002 | K012018 | BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 Acmi Corporation | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-9F Electrohydraulic Lithotripsy Probe,
9 FR x 60CM Terminated |
FFK | K980492 |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-5F Electrohydraulic Lithotripsy Probe,
5FR x 60CM Terminated |
FFK | K980492 |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-3F Electrohydraulic Lithotripsy Probe,
3 FR x 120CM Terminated |
FFK | K980492 |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-1F Electrohydraulic Lithotripsy Probe,
1.9 FR x 120CM Terminated |
FFK | K980492 |