FDA.reportPublic FDA data

USA Elite

Primary DI
00821925002784
Brand
USA Elite
Company
Gyrus ACMI, LLC
Model
ETO-CFR-25
Device description
USA Elite System Continuous Flow Resectoscope Timberlake Obturator, 25.6 Fr (8.5 mm) Color Coded Yellow
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890328000ADULT RESECTOSCOPECircon Video1990-02-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925002784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925002784008219250027848219250027840821925002784

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
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30
00821925041554OLYMPUS30452016-09-30
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002161Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002178Active working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002185Passive working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055573Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23
07613327053777NASTRYKER CORPORATIONHIH2016-09-23
07613327053777NASTRYKER CORPORATIONFAS2016-09-23
07613327053784NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONFAS2016-09-23
07613327053791NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONHIH2016-09-23