← Back to catalogue

Leksell Vantage Stereotactic System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K190887

by Elekta Instrument AB

Identity

Trade Name
Leksell Vantage Stereotactic System FDA UDI
Generic Name
Neurological stereotactic surgery system FDA UDI
Device Name
VANTAGE STARBURST 3/8 FDA UDI
Model / Reference
1072929 FDA UDI
Description
VANTAGE STARBURST 3/8 FDA UDI

Identifiers

Catalog Number
1072929 FDA UDI
Primary DI / UDI-DI
07340048311618 FDA UDI
510(k) Number
K190887 FDA 510(k)FDA UDI
FDA Product Code
HAW FDA 510(k)FDA UDI
GMDN Term
Neurological stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)FDA UDI
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Leksell Vantage Stereotactic System by Elekta Instrument AB — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Elekta Instrument AB

Sources (2)

  • FDA 510(k) K190887 24 fields · synced Jun 18, 2026
  • FDA UDI 016056de-51bb-44a9-b61e-4d01522e039b 35 fields · synced May 27, 2026