Company ยท US
Core Dynamics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1999. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 12 |
| HET | Laparoscope, Gynecologic (And Accessories) | 4 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | 2 |
| FHO | Pneumoperitoneum Needle | 1 |
| GAZ | Tubing, Noninvasive | 1 |
| GBW | Catheter, Peritoneal | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 1999 | K992250 | CORE AUDIBLE TROCAR II Core Dynamics, Inc. | GCJ |
| Sep 1, 1999 | K992190 | CORE POUCH Core Dynamics, Inc. | GCJ |
| Jan 22, 1996 | K955490 | LAPAROSCOPIC KNITTER Core Dynamics, Inc. | GCJ |
| Oct 20, 1995 | K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM Core Dynamics, Inc. | GCJ |
| Oct 16, 1995 | K953409 | LAPAROSCOPIC TROCAR Core Dynamics, Inc. | GCJ |
| May 5, 1995 | K950457 | CANNUAL AND TROCAR, SUPERPUBIC Core Dynamics, Inc. | HET |
| Jul 28, 1994 | K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR Core Dynamics, Inc. | GCJ |
| May 18, 1994 | K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE Core Dynamics, Inc. | GCJ |
| Mar 17, 1994 | K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET Core Dynamics, Inc. | HET |
| Jan 11, 1994 | K932021 | ENTREE CANNULA FASCIA ANCHORS Core Dynamics, Inc. | FBM |
| Jan 11, 1994 | K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER Core Dynamics, Inc. | HET |
| Nov 12, 1993 | K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO Core Dynamics, Inc. | GBW |
| Oct 15, 1993 | K933909 | SCOPE WASH Core Dynamics, Inc. | GCJ |
| Sep 7, 1993 | K931138 | CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP Core Dynamics, Inc. | GCJ |
| Jul 28, 1993 | K932022 | ENTREE THORACOSCOPY CANNULA SET Core Dynamics, Inc. | GCJ |
| Jul 23, 1993 | K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES Core Dynamics, Inc. | GAZ |
| Jun 25, 1993 | K924410 | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION Core Dynamics, Inc. | GEI |
| Jul 14, 1992 | K922655 | SUCTION/IRRIGATION Y TUBING SET Core Dynamics, Inc. | GCJ |
| Nov 27, 1991 | K914426 | ENTREE NEEDLE Core Dynamics, Inc. | FHO |
| Jul 19, 1991 | K911813 | ENTREE CANNULA Core Dynamics, Inc. | FBM |
| Apr 29, 1991 | K910246 | CORE DISPOSABLE SUCTION/IRRIGATION TUBING Core Dynamics, Inc. | GCJ |
| Sep 24, 1990 | K901413 | CORE DISPOSABLE INSUFFLATION TUBING Core Dynamics, Inc. | HES |
| Jun 8, 1990 | K901407 | CORE DISPOSABLE TROCARS Core Dynamics, Inc. | HET |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||