Core Dynamics, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Core Dynamics, Inc.” (first 1990, latest 1999), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 92 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 | 12 | 12 |
| HET | Laparoscope, Gynecologic (And Accessories) | 4 | 4 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | 2 | 2 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| GBW | Catheter, Peritoneal | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (14)
- Obstetrics and Gynecology (5)
- Gastroenterology and Urology (3)
- General Hospital (1)
Most recent Core Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992250 | CORE AUDIBLE TROCAR II | GCJ | 1999-09-24 | 80 |
| K992190 | CORE POUCH | GCJ | 1999-09-01 | 64 |
| K955490 | LAPAROSCOPIC KNITTER | GCJ | 1996-01-22 | 80 |
| K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | GCJ | 1995-10-20 | 92 |
| K953409 | LAPAROSCOPIC TROCAR | GCJ | 1995-10-16 | 88 |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | HET | 1995-05-05 | 91 |
| K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | GCJ | 1994-07-28 | 38 |
| K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE | GCJ | 1994-05-18 | 163 |
| K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET | HET | 1994-03-17 | 318 |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | FBM | 1994-01-11 | 263 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Core Dynamics, Inc..
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.
- Core Essence Orthopaedics, LLC (6 510(k)s)
- Core Medical, Inc. (3 510(k)s)
- Core 3D Protech, S.L. (1 510(k)s)
- Core Access Surgical Technologies, Inc. (1 510(k)s)
- Core Healthcare , Ltd. (1 510(k)s)
- Core Scientific , Ltd. (1 510(k)s)
- Core Scientific Creation , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Core Dynamics, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Core Dynamics, Inc.” (first 1990, 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 Core Dynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Core Dynamics, Inc. is 92 days.
Which FDA product codes appear under Core Dynamics, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 12); HET (Laparoscope, Gynecologic (And Accessories), 4); FBM (Cannula And Trocar, Suprapubic, Non-Disposable, 2).
Next steps
- See all 23 Core Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Core Dynamics, 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.