TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Registration 2938071FEI 2938071SAN RAMON, CA
Owner/operator: TTI MEDICAL
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 19
- Added, last 12 months
- 4
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 19
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| EOQ | ACCU-Beam CO2 Laser Bronchoscope SetBronchoscope (Flexible Or Rigid)Added Jul 17, 2026 | Class 2 | 21 CFR 874.4680 | K870063 |
| GEI | ACCU-Surg Bipolar Laparoscopic ElectrodesElectrosurgical, Cutting & Coagulation & AccessoriesAdded Jul 17, 2026 | Class 2 | 21 CFR 878.4400 | K971677 |
| GEI | ACCU-SURG Laparoscopic Instrument SElectrosurgical, Cutting & Coagulation & Accessories | Class 2 | 21 CFR 878.4400 | K910978 |
| GCJ | ACCU-Beam Laparoscopic Instrument SLaparoscope, General & Plastic Surgery | Class 2 | 21 CFR 876.1500 | K921208 |
| GCJ | ACCU-Beam Tissue Drill & Aspiration/Injection NeedleLaparoscope, General & Plastic Surgery | Class 2 | 21 CFR 876.1500 | K934398 |
| HHR | ACCU-BEAM MicromanipulatorLaser, Surgical, Gynecologic | Class 2 | 21 CFR 884.4550 | K864378 |
| HHR | ACCU-BEAM Laparoscope CouplersLaser, Surgical, Gynecologic | Class 2 | 21 CFR 884.4550 | K870046 |
| GCT | ACCU-Beam 300W Xenon Light SourceLight Source, Endoscope, Xenon ArcAdded Jul 17, 2026 | Class 2 | 21 CFR 876.1500 | K951895 |
| GEX | ACCU-BEAM Fiber Optic HandpiecePowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K952006 |
| GEX | ACCU-BEAM CO2 Laser HandpiecesPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K945648 |
| GEX | ACCU-BEAM Laser FibersPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K890922 |
| GEX | ACCU-BEAM CO2 Laser Wave GuidePowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K895656 |
and 7 more on your full dossier
What changed
- Jul 17, 2026Listing added: EOQ — ACCU-Beam CO2 Laser Bronchoscope Set (K870063)
- Jul 17, 2026Listing added: GEI — ACCU-Surg Bipolar Laparoscopic Electrodes (K971677)
- Jul 17, 2026Listing added: GCT — ACCU-Beam 300W Xenon Light Source (K951895)
- Jul 17, 2026Listing added: GEX — ACCU-Beam Laser Block Beamsplitter (K963193)