Acmi Invisio Icn, Models ICN-0564 and ICN-0565
FDA 510(k) K042225 · Acmi Corporation
510(k) numberK042225
Submission
- Device name
- Acmi Invisio Icn, Models ICN-0564 and ICN-0565
- Applicant
- Acmi Corporation
Southborough, MA, US - Received
- August 17, 2004
- Decision date
- September 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAJ – Cystoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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 510(k)s with product code FAJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…FAJ · Traditional | Olympus Winter & Ibe GmbH | 05/21/2026SE |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse…FAJ · Traditional | Verathon Medical (Canada) Ulc | 05/11/2026SE |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…FAJ · Traditional | Strauss Surgical USA | 04/16/2026SE |
| K253905 | PrimeSight UltraView SystemFAJ · Traditional | Cogentix Medical, Inc. | 04/07/2026SE |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional | American Medical Endoscopy, Inc. | 03/27/2026SE |
| K253226 | UV5000W HandleFAJ · Special | Uroviu Corporation | 10/23/2025SE |
| K251140 | Zenflow Spring ScopeFAJ · Traditional | Zenflow, Inc. | 09/23/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 09/15/2025SE |
| K250797 | UV5000 HandleFAJ · Traditional | Uroviu Corporation | 09/11/2025SE |
| K243653 | KARL STORZ HOPKINS Telescopes for UrologyFAJ · Traditional | Karl Storz SE & CO. KG | 08/13/2025SE |
More from Karl Storz SE & CO. KG
| 510(k) | Device | Decision |
|---|---|---|
| K061975 | Plasmaseal Open Forceps, Models 2103PK and 91701PKGEI · Special | 08/10/2006SE |
| K060752 | Acmi Dur-Hl Laser SystemsGEX · Traditional | 05/25/2006SE |
| K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemFBN · Traditional | 03/31/2006SE |
| K051593 | Uropass Ureteral Access Sheath, Model 61224KNY · Traditional | 09/02/2005SE |
| K052044 | Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALFGB · Special | 08/16/2005SE |
| K043581 | Dual Lumen CatheterEYB · Special | 03/03/2005SE |
| K042069 | Invisio Irl Digital Rigid Laparoscope SystemGCJ · Traditional | 11/01/2004SE |
| K031758 | Acmi M4 TelescopesFBP · Traditional | 09/02/2003SE |
| K030960 | Ecn Electronic Video CystonephroscopeFAJ · Traditional | 07/16/2003SE |
| K030935 | Berkeley V-10 Vacuum Curettage SystemHHI · Traditional | 06/23/2003SE |
Questions and answers
When was Acmi Invisio Icn, Models ICN-0564 and ICN-0565 cleared by the FDA?
Acmi Invisio Icn, Models ICN-0564 and ICN-0565 (K042225) received a 510(k) decision of Substantially Equivalent on September 10, 2004, 24 days after the submission was received.
What is the product code of K042225?
The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.