FDA.reportPublic FDA data

AURORA® Surgiscope®

Primary DI
00850002332247
Brand
AURORA® Surgiscope®
Company
Integra Lifesciences Corporation
Model
ASX15/80
Catalog number
ASX15/80
Device description
AURORA® Surgiscope® System
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWGEndoscope, Neurological
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201840000
K250752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201840000Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics2020-11-04GWG
K250752000AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation2025-04-09GWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002332247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002332247008500023322478500023322470850002332247

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical neuroscope, single-useA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the central nervous system (CNS). It is inserted into the body through a pre-drilled hole in the cranium for neuroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length80Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
00810004821163Digital MurphyScope Endoscope, 0 degreeCLARUS MEDICAL, LLCGWG2026-06-22
07613327631395N/ASTRYKER CORPORATIONGWG2026-06-19
07613327631388N/ASTRYKER CORPORATIONGWG2026-06-16
07613327632774N/ASTRYKER CORPORATIONGWG2026-06-16
08800112400161cCeLLVPIX Medical, Inc.GWG2026-05-11
08800112400178cCeLLVPIX Medical, Inc.GWG2026-05-11
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
076133276089151788STRYKER CORPORATIONGWG2023-12-11
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23