VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH— 510(k) K110958
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K110958 for VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH, Substantially Equivalent on 2011-08-01. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code FQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5475
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Petersburg, FL, US
Recent devices under product code FQH
view allMore clearances from Smith & Nephew, Inc.
view all- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code FQH
product code FQH- Injury
- 170
- Malfunction
- 2,513
- Other
- 1
- Total
- 2,684
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.