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510(k) K031001

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE by Acmi Corporation — Product Code FAS

K031001 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "ACMI VISTA CTR BIPOLAR LOOP ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 21, 2003. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Acmi Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2003
Date Received
March 31, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Acmi Corporation

  • K061975 — PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK (August 10, 2006)
  • K060752 — ACMI DUR-HL LASER SYSTEMS (May 25, 2006)
  • K060269 — ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (March 31, 2006)
  • K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (September 2, 2005)
  • K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (August 16, 2005)
  • K043581 — DUAL LUMEN CATHETER (March 3, 2005)
  • K042069 — INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (November 1, 2004)
  • K042225 — ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (September 10, 2004)
  • K031758 — ACMI M4 TELESCOPES (September 2, 2003)
  • K030960 — ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (July 16, 2003)

Other clearances for product code FAS

  • K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect (December 5, 2025)
  • K250522 — Multi4 System (June 27, 2025)
  • K240504 — PLASMA EDGE System (June 12, 2024)
  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K171965 — Resection Electrodes with HF cable (September 28, 2017)
  • K163090 — Plasma Edge System (May 23, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)

FDA data resources