MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY— 510(k) K041995
Substantially EquivalentUresil, LLC
FDA 510(k) clearance K041995 for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY, Substantially Equivalent on 2004-08-19. Applicant: Uresil, LLC. Device class: 1.
Clearance details
- Applicant
- Uresil, LLC
- Product code
- Code GBO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Skokie, IL, US
Recent devices under product code GBO
view all- K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL
- K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER
- K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
- K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
- K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
More clearances from Uresil, LLC
view allAdverse events under product code GBO
product code GBO- Death
- 8
- Injury
- 236
- Total
- 244
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.