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510(k) K060269

ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM by Acmi Corporation — Product Code FBN

K060269 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 2006. The device falls under product code FBN (Choledochoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Acmi Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2006
Date Received
February 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Choledochoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • 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)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)

Other clearances for product code FBN

  • K254153 — Single-use Video Scope; PB Digital Controller (April 3, 2026)
  • K253139 — Disposable Distal Cap (March 19, 2026)
  • K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, (January 20, 2026)
  • K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tange (September 12, 2025)
  • K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV (March 7, 2025)
  • K241444 — Biliary Pancreaticobiliary Scope System (January 21, 2025)
  • K233752 — Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ I (May 2, 2024)
  • K231497 — Choledochoscope System (March 6, 2024)
  • K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (October 17, 2023)
  • K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Fl (June 22, 2023)

FDA data resources