COBRA HAND PIECE— 510(k) K973366
Substantially EquivalentVidamed, Inc.
FDA 510(k) clearance K973366 for COBRA HAND PIECE, Substantially Equivalent on 1997-11-26. Applicant: Vidamed, Inc.. Device class: 2.
Clearance details
- Applicant
- Vidamed, Inc.
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code KNS
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
- K965199 — TUNA 5 CATHETER
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.