Tti Medical: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tti Medical” (first 1987, latest 1995), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Tti Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952006 | ACCU-BEAM FIBER OPTIC HANDPIECE | GEX | 1995-05-31 | 33 |
| K951895 | ACCU-BEAM 300W XENON LIGHT SOURCE | GCT | 1995-05-24 | 30 |
| K945648 | ACCU-BEAM C02 LASER HANDPIECE | GEX | 1995-02-24 | 99 |
| K921208 | ACCU-BEAM TUBE SET | GCJ | 1993-06-01 | 446 |
| K910978 | ACCU-BEAM LAPAROSCOPIC SYSTEM | GEI | 1991-11-07 | 245 |
| K895656 | ACCU-BEAM WAVEGUIDE | GEX | 1990-02-22 | 156 |
| K890922 | ACCU-BEAM YAG FIBER | GEX | 1989-05-15 | 80 |
| K870063 | CO2 LASER BRONCHOSCOPE SET | EOQ | 1987-03-09 | 61 |
| K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | HHR | 1987-03-05 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Tti Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tti Medical?
FDA lists 9 510(k) clearances under the applicant name “Tti Medical” (first 1987, latest 1995), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tti Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tti Medical is 80 days.
Which FDA product codes appear under Tti Medical?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); EOQ (Bronchoscope (Flexible Or Rigid), 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 9 Tti Medical clearances with predicates and recalls
- Run predicate analysis for product code GEX, Tti Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.