LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM— 510(k) K050639
Substantially EquivalentLumenis, Inc.
FDA 510(k) clearance K050639 for LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM, Substantially Equivalent on 2005-03-31. Applicant: Lumenis, Inc.. Device class: 2.
Clearance details
- Applicant
- Lumenis, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Lumenis, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 K050639
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 K050639.
Data sourced from openFDA. This site is unofficial and independent of the FDA.