URESIL THORA-FLO THORACENTESIS PROCEDURE KIT— 510(k) K872948
UnknownUresil Corp.
FDA 510(k) clearance K872948 for URESIL THORA-FLO THORACENTESIS PROCEDURE KIT, Unknown on 1987-11-27. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code JOL
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Skokie, IL, US
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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 JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
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.