URESIL GENERAL PURPOSE DRAINAGE CATHETER— 510(k) K912109
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K912109 for URESIL GENERAL PURPOSE DRAINAGE CATHETER, Substantially Equivalent on 1991-08-12. Applicant: Uresil Corp.. Device class: 1.
Clearance details
- Applicant
- Uresil Corp.
- 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
- Traditional
- Location
- Skokie, IL, US
Recent devices under product code GBO
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- K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
- K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
- K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
More clearances from Uresil Corp.
view all- K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
- K980278 — URESIL VASCU-FLO INFUSION CATHETER
- K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K980889 — URESIL NEPHRO-URETERAL STENT
Adverse 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.