Identity
- Trade Name
- Leksell Stereotactic System FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Leksell MPS Arc w Counter Scale - ARC ATTACHMENT FOR COUNTER SCALE FDA UDI
- Model / Reference
- 1040385 FDA UDI
- Description
- Leksell MPS Arc w Counter Scale - ARC ATTACHMENT FOR COUNTER SCALE FDA UDI
Identifiers
- Catalog Number
- 1040320 FDA UDI
- Primary DI / UDI-DI
- 07340201503119 FDA UDI
- 510(k) Number
- K152558 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Neurological stereotactic surgery system
Leksell Stereotactic System by Elekta Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurological stereotactic surgery system.
- Gauge for Softouch Registration Pointer — Brainlab SE · Class I
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
Cleared under the same submission
K152558 also covers:
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
- Leksell Stereotactic System — Elekta Solutions AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elekta Solutions AB
Sources (1)
- FDA UDI 9534ebd3-384a-47e8-84b3-afb96452772f 35 fields · synced Jun 6, 2026