ALM PRISMALIX (PRX) SURGICAL LIGHT— 510(k) K982063
Substantially EquivalentAlm Surgical Equipment, Inc.
FDA 510(k) clearance K982063 for ALM PRISMALIX (PRX) SURGICAL LIGHT, Substantially Equivalent on 1998-09-22. Applicant: Alm Surgical Equipment, Inc.. Device class: 2.
Clearance details
- Applicant
- Alm Surgical Equipment, Inc.
- Product code
- Code FSY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code FSY
view allMore clearances from Alm Surgical Equipment, Inc.
view allAdverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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 →
Recalls naming K982063
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982063.
Data sourced from openFDA. This site is unofficial and independent of the FDA.