FDA.report

ActivSight Laparoscope 10mm 0 Degree NIR

Primary DI
00850016403261
Brand
ActivSight Laparoscope 10mm 0 Degree NIR
Company
Activ Surgical, Inc.
Model
AS-LAP100
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K941541000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K941541000HSV LAPAROSCOPY SETHenke Sass Wolf of America, Inc.1994-05-16GCJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850016403261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016403261008500164032618500164032610850016403261

GMDN Terms

TermDefinition
Rigid video laparoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
079855777
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00850016403001ActivSight Light EngineAS-LE0012026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleAS-IM0012026-05-26
00850016403025ActivSIght Light GuideAS-LC0012026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerAS-AD0012026-05-26
00850016403049ActivSight Imaging Module Clean and Disinfect TrayAS-IMT0022026-05-26
00850016403063ActivSight Light Cable Sterilization TrayAS-LCT0012026-05-26
00850016403070ActivSight Imaging Module Tray for VHPAS-IMT0012026-05-26
00850016403087ActivSight Light Cable Adapter - StorzAS-AD0022026-05-26
00850016403094ActivSight Integrated Imaging ModuleAS-IM0022026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRAS-AD0052026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRAS-AD0032026-05-26
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRAS-LAP5302026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRAS-LAP10302026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayAS-SCT0012026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRAS-LAP502026-05-26

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