FDA.reportPublic FDA data

Accu-Beam

Primary DI
B1773184AS80
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
3184AS8
Device description
Wolf EndoAdapter, 8mm.
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HHRLaser, Surgical, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHRLaser, Surgical, GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870046000DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SETTti Medical1987-03-05HHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1773184AS80PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscope laser couplerA device used to connect a laser delivery system [e.g., the articulating arm of a carbon dioxide (CO2) laser] and a laparoscope; providing a coincidence between the aiming beam and the treatment beam at the target site. It typically consists of a lens housing including a set of lenses, a laparoscope adaptor, and a sleeve. It is attached to the laser delivery system at the proximal end and to the laparoscope at the distal end, and the sleeve is placed inside the working channel of the laparoscope to provide a path for the laser. The device is typically used for a procedure using a laser type which wavelength is not appropriate for fibreoptic cable transmission. 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
B1779450F0Accu-Surg9450F2026-04-21
B177700500180Accu-Beam700500182026-04-14
B177950134700Accu-Beam9501-34/702022-02-23
B177950150700Accu-Beam9501-50/702020-06-30
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
B17781860Accu-Beam81862020-05-19
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B177301650T5320Accu-Beam301650T-5322021-11-19
B1773122602B0Accu-Beam31226-02B 2021-06-25
B1773126002B0Accu-Beam31260-02B 2021-06-25
B1778194101M0Accu-Beam8194101M2019-05-30
B1778194101M010Accu-Beam8194101M-012019-05-30
B1772000029800Accu-Beam2000029802019-01-25
B1772000039490Accu-Beam2000039492019-01-15
B1772010TTI0Accu-Beam2010TTI2018-07-25
B17725045120Accu-Beam25045122018-08-27
B17725045130Accu-Beam25045132018-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B177700500180Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2026-04-14
B17770700Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2026-02-20
B1771104R0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2025-02-25
B177062537602T0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-08-06
B17770560Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-02-20
B1777021580Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-09
B1777021650Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-09
B177A55014900TTI0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-04
B1771109R0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2022-08-23
17290110122215Tip ClearLift QS 5x5 with Depth Control Set (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122222Tip ClearLift QS 5x5 without Depth Control Set (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122239ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female ALMA LASERS LTD.HHR2021-12-30
17290110122246Tip ClearLift QS CVD (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122253Tip ClearLift QS KTP 532 3mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122260Tip ClearLift QS KTP 532 4mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122277Tip ClearLift QS Scanner 5x5 & CVD (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122284Tip ClearLift QS 3mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122291Tip ClearLift QS 5mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122307Tip ClearLift QS 10mm (Female)ALMA LASERS LTD.HHR2021-12-30
B1777065PL0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2021-09-24
B17770580Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2021-04-09
B17770690Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2020-12-02
B1777040ES0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2020-08-31
17290110121942Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / ProALMA LASERS LTD.HHR2020-06-24
B17711230Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2019-12-17
B1777065P0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-19
B1773113CAB60Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113OLY50Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113STD510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113STD60Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18