VYCOR SURGICAL ACCESS SYSTEMS— 510(k) K060973
Substantially EquivalentVycor Medical, LLC
FDA 510(k) clearance K060973 for VYCOR SURGICAL ACCESS SYSTEMS, Substantially Equivalent on 2006-07-26. Applicant: Vycor Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Vycor Medical, LLC
- Product code
- Code GZT
- Device class
- Class 2
- Regulation
- 21 CFR 882.4800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code GZT
view all- K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
- K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
- K202072 — MindsEye Expandable Port
- K180610 — Geister retractor for neuro - and spine surgery
- K172433 — NICO BrainPath
Recalls naming K060973
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 K060973.
Data sourced from openFDA. This site is unofficial and independent of the FDA.