# Acmi Corporation

- Location (FDA's records): Southborough, MA
- FDA decisions: 16 (2002–2006): 16 510(k) clearances
- Product codes: GEI (2), FAJ (2), FGB (2), GEX (1), EYB (1), KNY (1), GCJ (1), OCU (1), FAS (1), FBN (1), HIH (1), FBP (1)
- Predicates its devices cite: 31 (4 its own); citations of its devices by later devices: 26 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Circon Video: 7 (https://510kreport.com/company/circon-video)
- Surgitek: 2 (https://510kreport.com/company/surgitek)
- Circon Corp.: 2 (https://510kreport.com/company/circon)
- Olympus America, Inc.: 2 (https://510kreport.com/company/olympus-america)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Gyrus Medical, Inc.: 1 (https://510kreport.com/company/gyrus-medical)
- Wavelight Laser Technologie AG: 1 (https://510kreport.com/company/wavelight-laser-technologie)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)

## Firms that cite its devices most
- Gyrus Acmi, Inc.: 6 (https://510kreport.com/company/gyrus-acmi)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Richard Wolf Medical Instruments Corp.: 2 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Promepla Sam: 1 (https://510kreport.com/company/promepla-sam)
- Olympus Surgical Technologies America: 1 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Thermedx, LLC: 1 (https://510kreport.com/company/thermedx)
- Womancare Global: 1 (https://510kreport.com/company/womancare-global)

## Its most-cited devices
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), cited by 7
- K030935: Berkeley V-10 Vacuum Curettage System (2003), cited by 3
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), cited by 2
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (2004), cited by 2
- K030960: Ecn Electronic Video Cystonephroscope (2003), cited by 2
- K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL (2005), cited by 2

## Recent decisions
- K061975: Plasmaseal Open Forceps, Models 2103PK and 91701PK (Aug 10, 2006)
- K060752: Acmi Dur-HL Laser Systems (May 25, 2006)
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (Mar 31, 2006)
- K051593: Uropass Ureteral Access Sheath, Model 61224 (Sep 2, 2005)
- K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL (Aug 16, 2005)
- K043581: Dual Lumen Catheter (Mar 3, 2005)
- K042069: Invisio Irl Digital Rigid Laparoscope System (Nov 1, 2004)
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (Sep 10, 2004)

Source page: https://510kreport.com/company/acmi