Endotec, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Endotec, Inc.” (first 1991, latest 2009), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 187 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 1 | 1 |
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Review panels
Most recent Endotec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | JWH | 2009-02-20 | 277 |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | JWH | 2002-01-30 | 169 |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | HSD | 1999-10-15 | 88 |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | MJT | 1999-04-29 | 290 |
| K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT | LPH | 1997-02-12 | 187 |
| K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP | LPH | 1997-02-12 | 187 |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | JDI | 1996-10-03 | 248 |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | KWT | 1996-08-26 | 210 |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | GEI | 1995-06-06 | 221 |
| K944465 | CARRIER, LIGATURE (79 GEJ) | GCJ | 1994-09-28 | 16 |
5 earlier clearances. See the full list in Caduvo.
Recalls
20 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2011-09-21.
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 Endotec, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Endotec, Inc.” (first 1991, latest 2009), across 10 product codes in 2 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 Endotec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endotec, Inc. is 187 days.
Which FDA product codes appear under Endotec, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 2); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2).
Next steps
- See all 15 Endotec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Endotec, Inc.'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.