FDA.reportPublic FDA data

Accu-Beam

Primary DI
B17793030
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
9303
Device description
Internal Cannula, 2.4mm x 27.4cm.
Published
2016-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910978000ACCU-BEAM LAPAROSCOPIC SYSTEMTti Medical1991-11-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B17793030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be used for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is fitted with a long syringe-like nozzle that is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., clamps, filters, spikes) are not included (i.e., not a tubing set). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery; it is not an ophthalmic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
130213366
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B17731226455L0Accu-Beam31226-455L2026-10-08
B17700100852TSS0Accu-Beam0010-0852T-SS2026-09-30
B17700100853TSS0Accu-Beam0010-0853T-SS2026-09-30
B1773122602B0Accu-Beam31226-02B2021-06-25
B17770590Accu-Beam70592026-07-28
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B1773126002B0Accu-Beam31260-02B2021-06-25
B17704342043D0Accu-Beam04342043D2017-10-26
B17704342044C0Accu-Beam04342044C2017-10-26
B17770080Accu-Beam70082016-07-05
B1779450F0Accu-Surg9450F2026-04-21
B177950134700Accu-Beam9501-34/702022-02-23
B177950150700Accu-Beam9501-50/702020-06-30
B177700500180Accu-Beam700500182026-04-14
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
B17781860Accu-Beam81862020-05-19
B177301650T5320Accu-Beam301650T-5322021-11-19

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Primary DI, Brand, Company table
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