Endo Technic Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Endo Technic Corp.” (first 1986, latest 1999), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 128 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 | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| EKM | Gutta-Percha | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | 1 | 1 |
Review panels
Most recent Endo Technic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990908 | MILLENNIUM | MXF | 1999-05-27 | 70 |
| K971459 | DERMALASE | GEX | 1997-07-18 | 88 |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | HET | 1994-08-24 | 686 |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | HET | 1994-03-09 | 390 |
| K925114 | LAPAROSCOPIC INSTRUMENTS | HFI | 1994-02-28 | 507 |
| K924058 | TROCAR | GCJ | 1993-03-30 | 230 |
| K914825 | 1-125 ENDOSEED | KXK | 1992-03-19 | 143 |
| K910200 | LASER-35 | GEX | 1991-05-09 | 114 |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | EKS | 1987-02-27 | 70 |
| K862129 | SET CANAL SEALER PASTE | EKM | 1986-07-22 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Endo Technic Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Endo Lase, Inc. (24 510(k)s)
- Endo GI Medical (2 510(k)s)
- Endo Optics, Inc. (2 510(k)s)
- Endo Surgical Concepts, Inc. (2 510(k)s)
- Endo Surgical Devices, Inc. (2 510(k)s)
- Endo Tools Therapeutics S.A. (2 510(k)s)
- Endo Twinn B.V. (2 510(k)s)
- Endo Smart Cap Co. (1 510(k)s)
- Endo Vantage, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endo Technic Corp.?
FDA lists 10 510(k) clearances under the applicant name “Endo Technic Corp.” (first 1986, latest 1999), across 8 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 Endo Technic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endo Technic Corp. is 128 days.
Which FDA product codes appear under Endo Technic Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); EKM (Gutta-Percha, 1).
Next steps
- See all 10 Endo Technic Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Endo Technic Corp.'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.