FDA.reportPublic FDA data

Wells Johnson Elite Infiltrator/Aspirator

Primary DI
B458205061000
Brand
Wells Johnson Elite Infiltrator/Aspirator
Company
The Wells Johnson Company
Model
20506100
Catalog number
20-5061-00
Device description
Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz
Published
2023-11-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832274000ASPIRATORWells Johnson Co.1983-10-20BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B458205061000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction pumpAn electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048931625
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B458205997000HVP Cart2059970020-5997-002026-04-20
B458205998000Wells Johnson Hymen Cart2059980020-5998-002026-04-20
B458205066000Wells Johnson Elite Infiltrator/Aspirator2050660020-5066-002023-11-20
B458201300000DEL VECCHIO RE-INJECTION, 14g2013000020-1300-002025-09-10
B458201826020TABLE, VTS, 240VAC2018260220-1826-022025-09-08
B458201550000C-MAX2015500020-1550-002025-09-05
B458201826000TABLE, VTS, 240VAC2018260020-1826-002023-08-31
B4582013390003-PORT RADIAL VT2013390020-1339-002023-07-19
B458201314000"DEL VECCHIO 12-HOLE, 4MM, 1"" BLUE ERGO"2013140020-1314-002025-07-28
B458208300000HVC3™ 2083000020-8300-002024-10-08
B458205186000Small Volume Harvesting Canister250ml20-5186-002025-02-05
B458205187000Small Volume Harvesting Canister500ml20-5187-002025-02-05
B458205173000High Volume Harvesting Canister1000ml (1L)20-5173-002023-07-14
B458205174000High Volume Harvesting Canister2000ml (2L)20-5174-002023-07-14
B458205175000High Volume Harvesting Canister3000ml (3L)20-5175-002023-07-14
B458205188000High Volume Harvesting Canister5000ml (5L)20-5188-002023-07-14
B458201825000TABLE, VTS, 120VAC2018250020-1825-002023-08-31
B458201266000FISCHER (ALOUF)2012660020-1266-002024-04-19
B458201360000INFILTRATION CANNULA SET, WIS (2)2013600020-1360-002024-02-23
B458201046020KHOURI CANNULA SET2010460220-1046-022024-01-23

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Primary DI, Brand, Company table
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