Menlo Care Aquastent Set
FDA 510(k) K923394 · Menlo Care, Inc.
510(k) numberK923394
Submission
- Device name
- Menlo Care Aquastent Set
- Applicant
- Menlo Care, Inc.
Menlo Park, CA, US - Received
- July 10, 1992
- Decision date
- November 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAD – Stent, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4620
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| K251469 | Endura Ureteral Stent and Stent SetFAD · Traditional | Cathegenix (Xiamen) Co., Ltd. | 12/19/2025SESK |
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 06/18/2025SE |
| K243830 | Disposable ureteral stentFAD · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 05/14/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | Boston Scientific Corporation | 04/15/2025SE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/22/2024SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | Boston Scientific Corporation | 11/10/2022SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | Coloplast Corp. | 06/08/2022SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/17/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | Coloplast Corp. | 02/16/2022SESK |
More from Coloplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K964447 | Picc Catheter/Midline CatheterLJS · Traditional | 04/16/1997SE |
| K951620 | Midmark Midline CatheterFOZ · Traditional | 04/04/1996SE |
| K945521 | Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep TrayFOZ · Traditional | 04/06/1995SE |
| K950737 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K944968 | Landmark Midline CatheterFOZ · Traditional | 03/29/1995SE |
| K943893 | Percutaneous Grainage CatheterLJE · Traditional | 03/07/1995SE |
| K943143 | Biliary StentFGE · Traditional | 02/28/1995SE |
| K930048 | Safe-Picc CatheterFOZ · Traditional | 05/12/1994SE |
| K933941 | Menlo Care Urinary Diversion StentFAD · Traditional | 03/31/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | 02/09/1994SE |
Questions and answers
When was Menlo Care Aquastent Set cleared by the FDA?
Menlo Care Aquastent Set (K923394) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 494 days after the submission was received.
What is the product code of K923394?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.