LATEX ULTRASONIC PROBE COVER— 510(k) K022156
Substantially EquivalentPleasure Latex Products Sdn. Bhd.
FDA 510(k) clearance K022156 for LATEX ULTRASONIC PROBE COVER, Substantially Equivalent on 2003-09-11. Applicant: Pleasure Latex Products Sdn. Bhd.. Device class: 2.
Clearance details
- Applicant
- Pleasure Latex Products Sdn. Bhd.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Jeram, Selangor Darul Ehsan, MY
Recent devices under product code ITX
view allMore clearances from Pleasure Latex Products Sdn. Bhd.
view all- K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
- K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
- K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE
- K002571 — MULITPLE MALE LATX CONDOM
- K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.