FDA.reportPublic FDA data

Microtable System

Primary DI
00196852534531
Brand
Microtable System
Company
Gsb LLC
Model
D
Catalog number
002
Device description
The Microtable System is a patient-specific surgical adapter designed to be secured on a skull-based anchor mounting set to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy.
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132611000MICROTABLE SYSTEMFred Haer Company, Inc.2014-03-06HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852534531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852534531001968525345311968525345310196852534531

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079198739
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21