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510(k) K042225

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 by Acmi Corporation — Product Code FAJ

K042225 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565". The FDA issued a decision of Substantially Equivalent on September 10, 2004. The device falls under product code FAJ (Cystoscope 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
September 10, 2004
Date Received
August 17, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

To examine and perform procedures within the urinary tract. 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)
  • 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)
  • 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 FAJ

  • K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 (May 21, 2026)
  • K253696 — CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse D (May 11, 2026)
  • K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x (April 16, 2026)
  • K253905 — PrimeSight UltraView System (April 7, 2026)
  • K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (March 27, 2026)
  • K253226 — UV5000W Handle (October 23, 2025)
  • K251140 — Zenflow Spring Scope (September 23, 2025)
  • K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
  • K250797 — UV5000 Handle (September 11, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)

FDA data resources