Core Dynamics, Inc.
Jacksonville, FL, US
Core Dynamics, Inc. appears in FDA device records in Jacksonville, FL. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Core Dynamics, Inc. between 1990 and 1999. The busiest year on record is 1993, with 6. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 6 |
| 1994 | 5 |
| 1995 | 3 |
| 1996 | 1 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992250 | CORE AUDIBLE TROCAR II | GCJ | Substantially Equivalent | |
| K992190 | CORE POUCH | GCJ | Substantially Equivalent | |
| K955490 | LAPAROSCOPIC KNITTER | GCJ | Substantially Equivalent | |
| K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | GCJ | Substantially Equivalent | |
| K953409 | LAPAROSCOPIC TROCAR | GCJ | Substantially Equivalent | |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | HET | Substantially Equivalent | |
| K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | GCJ | Substantially Equivalent | |
| K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE | GCJ | Substantially Equivalent | |
| K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET | HET | Substantially Equivalent | |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | FBM | Substantially Equivalent | |
| K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER | HET | Substantially Equivalent | |
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | GBW | Substantially Equivalent | |
| K933909 | SCOPE WASH | GCJ | Substantially Equivalent | |
| K931138 | CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP | GCJ | Substantially Equivalent | |
| K932022 | ENTREE THORACOSCOPY CANNULA SET | GCJ | Substantially Equivalent | |
| K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | GAZ | Substantially Equivalent | |
| K924410 | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION | GEI | Substantially Equivalent | |
| K922655 | SUCTION/IRRIGATION Y TUBING SET | GCJ | Substantially Equivalent | |
| K914426 | ENTREE NEEDLE | FHO | Substantially Equivalent | |
| K911813 | ENTREE CANNULA | FBM | Substantially Equivalent | |
| K910246 | CORE DISPOSABLE SUCTION/IRRIGATION TUBING | GCJ | Substantially Equivalent | |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | HES | Substantially Equivalent | |
| K901407 | CORE DISPOSABLE TROCARS | HET | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FBMCannula And Trocar, Suprapubic, Non-Disposable
- GBWCatheter, Peritoneal
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FHOPneumoperitoneum Needle
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain