FDA.reportPublic FDA data

IEC-Innoview GmbH

Primary DI
B192300057000
Brand
IEC-Innoview GmbH
Company
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
Model
30-0057-00
Catalog number
30-0057-00
Device description
4.0 mm, 30 deg. Cystoscope, l=302mm, autoclavable ( Cysto sheath ONLY-NOT Resectoscope/Working Element )
Published
2016-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992983000BAHO AUTOCLAVABLE CYSTOSCOPEInnovative Endoscopy Components, LLC1999-10-07FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B192300057000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid cystoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Length302Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010741028
Device count
1
DM exempt
true
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
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
B192300049000IEC-Innoview GmbH30-0049-0030-0049-002023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20