PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)— 510(k) K854911
Substantially EquivalentAngiomed U.S., Inc.
FDA 510(k) clearance K854911 for PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER), Substantially Equivalent on 1986-01-24. Applicant: Angiomed U.S., Inc.. Device class: 1.
Clearance details
- Applicant
- Angiomed U.S., Inc.
- 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
- Anaheim, CA, US
Recent devices under product code GBO
view all- K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
- 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)
More clearances from Angiomed U.S., Inc.
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.