FDA.reportPublic FDA data

Non-ICG 5mm Laparoscope (0 Deg)

Primary DI
G465FG16000
Brand
Non-ICG 5mm Laparoscope (0 Deg)
Company
Smartsurgn Inc.
Model
FG-16
Device description
Non-ICG 5mm Laparoscope (0 Deg)
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031974000ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0Asap Endoscopic Products GmbH2003-09-29HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G465FG16000PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
115617378
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G465FG13240Light CableFG 13242024-07-17
G465FG12000Non-ICG 4mm Sinuscope (70 Deg)FG-122025-08-27
G465FG14000Non-ICG 4mm Sinuscope (30 Deg)FG-142025-08-27
G465FG15000Non-ICG 4mm Sinuscope (0 Deg)FG-152025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)FG-172025-08-27
G465100300AirSurgN Insufflator100302025-04-22
G465FG1800Monitor 55 InchFG-182025-03-13
G465FG11220OptIcSurgNFG11222024-01-30
G465FG11230OptIcSurgNFG11232024-01-30
E30000019EyeRSurgN100102023-11-20
G465FG13140View4SurgNFG13142023-10-20
G465100100EyeRSurgN100102023-10-16
G465100200IRLightSurgN100202023-10-16
G465100400PrizMCurgN100402023-10-16

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