Flexible Ureteronephrosocope
FDA 510(k) K924135 · Applied Medical Resources
510(k) numberK924135
Submission
- Device name
- Flexible Ureteronephrosocope
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- August 18, 1992
- Decision date
- April 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 FEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/DisinfectorFEB · Traditional | Wassenburg Medical, Inc. | 12/19/2024SE |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
| K201920 | Endoscope Reprocessor OER-EliteFEB · Special | Olympus Medical Systems Corp. | 09/01/2020SE |
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | Advanced Sterilization Products (Asp) | 04/23/2019SE |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
More from Medivators, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…KGW · Special | 04/24/2026SE |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…KGW · Traditional | 02/23/2026SE |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion)GEI · Special | 11/04/2025SE |
| K252442 | Kii Structural Balloon Access SystemGCJ · Traditional | 10/31/2025SE |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI · Traditional | 10/31/2025SE |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | 10/02/2025SE |
| K232880 | Inzii Ripstop Redeployable Retrieval SystemGCJ · Special | 11/01/2023SE |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI · Special | 10/14/2022SE |
| K220969 | GelPOINT V-Path Vaginal Access SystemMOK · Traditional | 09/16/2022SE |
| K211043 | Alexis Contained Extraction SystemGCJ · Traditional | 03/31/2022SE |
Questions and answers
When was Flexible Ureteronephrosocope cleared by the FDA?
Flexible Ureteronephrosocope (K924135) received a 510(k) decision of Substantially Equivalent on April 14, 1993, 239 days after the submission was received.
What is the product code of K924135?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.