USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8
FDA 510(k) K023358 · Acmi Corporation
510(k) numberK023358
Submission
- Device name
- USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8
- Applicant
- Acmi Corporation
Southborough, MA, US - Received
- October 7, 2002
- Decision date
- January 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGB – Ureteroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To perform various diagnostic and therapeutic 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 FGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional | MacroLux Medical Technology Co., Ltd. | 07/20/2026SE |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional | Anhui Happiness Workshop Instruments Co., Ltd. | 04/09/2026SE |
| K260013 | CVAC Image ProcessorFGB · Traditional | Calyxo, Inc. | 03/06/2026SE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 12/16/2025SE |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 12/16/2025SE |
| K253411 | Miniature Telescope for Urology (27033AA)FGB · Traditional | Karl Storz SE & CO. KG | 11/18/2025SE |
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| 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 |
| K042225 | Acmi Invisio Icn, Models ICN-0564 and ICN-0565FAJ · Special | 09/10/2004SE |
| K031758 | Acmi M4 TelescopesFBP · Traditional | 09/02/2003SE |
| K030960 | Ecn Electronic Video CystonephroscopeFAJ · Traditional | 07/16/2003SE |
Questions and answers
When was USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8 cleared by the FDA?
USA Series Dur 8 Elite, USA Series Dur 8, Models Dur 8E, Dur 8 (K023358) received a 510(k) decision of Substantially Equivalent on January 3, 2003, 88 days after the submission was received.
What is the product code of K023358?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.