Zamenix P— 510(k) K253505
Substantially EquivalentRoen Surgical, Inc.
FDA 510(k) clearance K253505 for Zamenix P, Substantially Equivalent on 2026-08-07. Applicant: Roen Surgical, Inc.. Device class: 2.
Summary
Roen Surgical's Zamenix P is filed under product code FGB, flexible or rigid ureteroscopes and accessories. The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Roen filed from Daejeon, South Korea. FDA found it substantially equivalent 280 calendar days after receipt (October 31, 2025 to August 7, 2026).
Clearance details
- Applicant
- Roen Surgical, Inc.
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Recent devices under product code FGB
view all- K261447 — CVAC® Aspiration System
- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.