FDA.reportPublic FDA data

AIM (Advanced Imaging Modality)

Primary DI
07613327059342
Brand
AIM (Advanced Imaging Modality)
Company
STRYKER CORPORATION
Model
0502537010
Catalog number
0502-537-010
Device description
HD Laparoscope, Autoclavable, 0 View Direction
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWNConfocal optical imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142310000
K210088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142310000Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy2014-12-02OWN
K2100880001688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM LaparoscopesStryker2021-04-13GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327059342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327059342076133270593427613327059342

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter
Outer Diameter5.4Millimeter

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016403025ActivSIght Light GuideActiv Surgical, Inc.OWN2026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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06971679949935Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
04048551418123n.a.Karl Storz GmbH & Co. KGOWN2025-08-11
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04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17