Company ยท US
Endomedix
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1994. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1994 | K934170 | ENDOMEDIX Y-ADAPTER Endomedix | OCX |
| Dec 2, 1993 | K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA Endomedix | FET |
| Aug 16, 1993 | K930499 | GRASPING FORCEPS FLEXIBLE STONE DISLODGER Endomedix | OCZ |
| Jun 9, 1993 | K930349 | STONE RETRIEVAL BASKET Endomedix | FFL |
| Feb 10, 1993 | K926004 | ENDOSCOPE AND ACCOSSORIES Endomedix | FGB |
| Nov 3, 1992 | K922837 | S1500 XENON LIGHT SOURCE Endomedix | HBI |
| Aug 3, 1992 | K922082 | LAPAROSCOPIC INTRODUCER Endomedix | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||