FDA.reportPublic FDA data

Strauss Surgical

Primary DI
00850033250626
Brand
Strauss Surgical
Company
AMERICAN MEDICAL ENDOSCOPY, INC.
Model
STS-URO-045-30
Published
2022-08-12
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
K173070000
K260271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173070000HSW Resection InstrumentsHenke-Sass, Wolf GmbH2018-06-08HIH
K260271000Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.2026-03-27FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033250626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033250626008500332506268500332506260850033250626

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
024725124
Device count
1
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143892505Strauss SurgicalSTS-LC-KO-10GR2024-08-05
00810143892512Strauss SurgicalSTS-LC-KK-10GR2024-04-08
00810143892529Strauss SurgicalSTS-LC-STR-10GR2024-04-08
00851925007700Strauss SurgicalSTS-LC-KD-10CLR2022-05-18
00851925007717Strauss SurgicalSTS-LC-KK-10CLR2022-05-18
00851925007724Strauss SurgicalSTS-LC-KK-3.8-10CLR2022-05-18
00851925007731Strauss SurgicalSTS-LC-KO-10CLR2022-05-18
00851925007748Strauss SurgicalSTS-LC-LIN-4810CLR2022-05-18
00851925007755Strauss SurgicalSTS-LC-STR-10CLR2022-05-18
00851925007762Strauss SurgicalSTS-LC-STR-3.8-10CLR2022-05-18
00851925007779Strauss SurgicalSTS-LC-XLS-4.82022-05-18
00810143891157Strauss SurgicalSTS-URO-001-16-SET2024-09-27
00810143891164Strauss SurgicalSTS-URO-001-17-SET2024-09-27
00810143891171Strauss SurgicalSTS-URO-001-19-SET2024-09-27
00810143891188Strauss SurgicalSTS-URO-001-21-SET2024-09-27
00810143891195Strauss SurgicalSTS-URO-001-23-SET2024-09-27
00810143891201Strauss SurgicalSTS-URO-001-25-SET2024-09-27
00810143890938Strauss SurgicalSTS-URO-040-252024-04-15
00810143890945Strauss SurgicalSTS-URO-001-162024-04-15
00810143890952Strauss SurgicalSTS-URO-020-162024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13