VIDAMED MODEDL 7600 RF GENERATOR— 510(k) K965061
Substantially EquivalentVidamed, Inc.
FDA 510(k) clearance K965061 for VIDAMED MODEDL 7600 RF GENERATOR, Substantially Equivalent on 1997-01-28. Applicant: Vidamed, Inc.. Device class: 2.
Clearance details
- Applicant
- Vidamed, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code GEI
view allMore clearances from Vidamed, Inc.
view all- K014224 — PRECISION PLUS TUNA OFFICE SYSTEM
- K012587 — RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
- K011787 — PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
- K002583 — TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
- K973366 — COBRA HAND PIECE
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.