Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2938071

FEI Number

2938071

Entity Name

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

City/State/Country

SAN RAMON, CA, US

Establishment Address

220 Porter Drive, Suite 120, SAN RAMON, CA 94583, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

TTI MEDICAL (Owner Number: 2938071)

Owner / Operator Contact Address

220 Porter Drive, Suite 120, San Ramon, CA 94583, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K952006

PMA Number

N/A

All Registered Proprietary Names

ACCU-SURG Laparoscopic Instrument S ACCU-Beam Tissue Drill & Aspiration/Injection Needle ACCU-Beam Laparoscopic Instrument S ACCU-BEAM CO2 Laser Handpieces Accu-Beam Instrument Tray VIDEO CAMERAS ACCU-BEAM UNIVERSA LAMPS ACCU-BEAM Micromanipulator ACCU-BEAM ACCU-BEAM ACCU-BEAM Fiber Optic Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-07-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-25
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-05-07
FWD	Camera, Television, Microsurgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	1996-06-13
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	1998-04-14
KEG	Lamps, Microscope	Pathology	Class 1	864.3600	1996-06-13
HHR	Laser, Surgical, Gynecologic	Obstetrics/Gynecology	Class 2	884.4550	2007-12-25
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	1992-12-03
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	1992-12-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-25

Official Correspondent

ALLEN HOWES

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TTI MEDICAL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2938071. Last updated year: 2026. Please use registration number 2938071 when referencing this establishment in official correspondence.