FDA.reportPublic FDA data

IEC-Innoview GmbH

Primary DI
B192300401000
Brand
IEC-Innoview GmbH
Company
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
Model
30-0401-00
Catalog number
30-0401-00
Device description
Bariatric 10 mm, 45 deg Laparoscope, L=425 mm, autoclavable
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K982276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982276000BAHO AUTOCLAVABLE LAPAROSCOPEMicroptix Int'L, LLC1999-02-18HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B192300401000PrimaryHIBCC0

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
Angle45degree
Length425Millimeter
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010741028
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B192300003000IEC-Innoview GmbH30-0003-0030-0003-002016-05-31
B192300004000IEC-Innoview GmbH30-0004-0030-0004-002016-05-23
B192300006000IEC-Innoview GmbH30-0006-0030-0006-002016-05-23
B192300008000IEC-Innoview GmbH30-0008-0030-0008-002016-05-23
B192300010000IEC-Innoview GmbH30-0010-0030-0010-002016-05-23
B192300011000IEC-Innoview GmbH30-0011-0030-0011-002016-05-24
B192300012000IEC-Innoview GmbH30-0012-0030-0012-002016-05-24
B192300054000IEC-Innoview GmbH30-0054-0030-0054-002016-06-02
B192300055000IEC-Innoview GmbH30-0055-0030-0055-002016-05-24
B192300057000IEC-Innoview GmbH30-0057-0030-0057-002016-05-24
B192300068000IEC-Innoview GmbH30-0068-0030-0068-002016-07-12
B192300311000IEC-Innoview GmbH30-0311-0030-0311-002016-05-24
B192300346000IEC-Innoview GmbH30-0346-0030-0346-002016-05-24
B192300348000IEC-Innoview GmbH30-0348-0030-0348-002016-05-24
B192300421000IEC-Innoview GmbH30-0421-0030-0421-002016-05-24
B192300514000IEC-Innoview GmbH30-0514-0030-0514-002016-05-26
B192300515000IEC-Innoview GmbH30-0515-0030-0515-002016-05-26
B192300646000IEC-Innoview GmbH30-0646-0030-0646-002016-07-12
B1921091313550Eberle10-91313-5510-91313-552023-06-08
B192300048000IEC-Innoview GmbH30-0048-0030-0048-002023-06-08

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