FDA.reportPublic FDA data

CONTROL

Primary DI
04260463849066
Brand
CONTROL
Company
Aktormed GmbH
Model
171906
Device description
for ENDOFIX exo,autoclavable
Published
2026-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OCVEndoscope Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCVEndoscope HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232405000ENDOFIX EXOAktormed GmbH2024-04-25OCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260463849066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463849066042604638490664260463849066

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537223815
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260463842333ENDOSCOPE CLAMP A1822332026-02-25
04260463845273STERILISATION TRAY1415272026-02-25
04260463846867ENDOSCOPE CLAMP B1516862026-02-25
04260463849127ENDOFIX EXO SET1719122026-02-25
04260463849271CONE ADAPTER1719272026-02-25
04260463849431Endofix EXO1719432025-07-30
04260463845181PROBE PIN2125182125182024-10-02
04260463842821STERILISATION TRAY XL1922821922822024-10-01
04260463844801CANTILEVER2124802124802024-10-01
04260463844825JOINT2124822124822024-10-01
04260463844993Dexter Endoscope Arm2124992124992024-10-01
04260463845907ENDOSCOPE CLAMP2225902225902024-10-01
04260463844276Joystick RH - IIA2024272022-04-12
04260463845433Joystick LH-US2125432022-04-12
04260463845440Joystick RH-US2125442022-04-12
04260463840919JOYSTICK-LH1720912021-04-29
04260463840650MOUNT-1B1720652021-04-29
04260463840667MOUNT-1A1720662021-04-29
04260463840674MOUNT-2A1720672021-04-29
04260463840681MOUNT-2B1720682021-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260463842333ENDOSCOPE CLAMP AAktormed GmbHOCV2026-02-25
04260463845273STERILISATION TRAYAktormed GmbHOCV2026-02-25
04260463846867ENDOSCOPE CLAMP BAktormed GmbHOCV2026-02-25
04260463849127ENDOFIX EXO SETAktormed GmbHOCV2026-02-25
04260463849271CONE ADAPTERAktormed GmbHOCV2026-02-25
04260463849431Endofix EXOAktormed GmbHOCV2025-07-30
04048551255902POINT SETTERKarl Storz GmbH & Co. KGOCV2020-03-02
04048551422328n.a.Karl Storz GmbH & Co. KGOCV2020-03-02
04048551422335n.a.Karl Storz GmbH & Co. KGOCV2020-03-02
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMBIOMET MICROFIXATION, INCOCV2019-06-17
04048551410912n.a.Karl Storz GmbH & Co. KGOCV2019-02-23
04048551337400VERSACRANEKarl Storz GmbH & Co. KGOCV2018-08-21
04048551366967n.a.Karl Storz GmbH & Co. KGOCV2018-08-21
04048551313114n.a.Karl Storz GmbH & Co. KGOCV2018-08-17
04048551193655n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551195475n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551193679n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551251669n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551405109n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551107539n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551111031KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111048KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111055KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111383KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111413KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551265222KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551265239KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551321560VERSACRANEKarl Storz GmbH & Co. KGOCV2016-09-23
04048551322475n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551322482n.a.Karl Storz GmbH & Co. KGOCV2016-09-23