510(k) Report

FDA applicant

Acmi Corporation

Southborough, MA16 decisions2002–20064 recalls

FDA records 16 decisions for Acmi Corporation (Southborough, MA) from 2002 to 2006: 16 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 31 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Acmi Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acmi Corporation since 2007.

Recalls per year

1in 2024

2008: 12019: 12023: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Acmi Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • FAJCystoscope And Accessories, Flexible/Rigid2decisions
  • FGBUreteroscope And Accessories, Flexible/Rigid2decisions
  • GEXPowered Laser Surgical Instrument1decision
  • EYBCatheter, Ureteral, Gastro-Urology1decision
  • KNYAccessories, Catheter, G-U1decision

Also: GCJ (1), OCU (1), FAS (1), FBN (1), HIH (1), FBP (1).

Whose devices does it build on?

Its devices cite 31 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 20067cite it
  • K030935Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 20033cite it
  • K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 20052cite it
  • K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 20042cite it
  • K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 20032cite it
  • K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 20052cite it

What has FDA decided for it lately?

  • K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006
  • K060752Acmi Dur-HL Laser SystemsAcmi Corporation · 2006
  • K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
  • K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 20052 recalls
  • K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation · 2005
  • K043581Dual Lumen CatheterAcmi Corporation · 20051 recall
  • K042069Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation · 2004
  • K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004

All 16 as Acmi Corporation →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K051593Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths…Sep 11, 2024Class II
  • K051593UroPass Ureteral Access Sheaths, 5 pieces/boxMay 19, 2023Class II
  • K030935Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product…Sep 12, 2019Class II
  • K043581Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608…Jun 25, 2008

Other applicant names beginning “Acmi”

FDA records each applicant name separately; these may or may not be the same firm.

Acmi-Circon Corporation 1