0.55% ORTH-PHTHALALDEHYDE SOLUTION— 510(k) K030004
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K030004 for 0.55% ORTH-PHTHALALDEHYDE SOLUTION, Substantially Equivalent on 2003-02-27. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code MED
- Device class
- Class 2
- Regulation
- 21 CFR 880.6885
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
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Recalls naming K030004
K-number listed on FDA's recall record- Z-2774-2015 — CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
- Z-2276-2012 — CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030004.
Data sourced from openFDA. This site is unofficial and independent of the FDA.