Data / Medical devices / United States / Endoplus
Endoplus: FDA-registered device maker in Mundelein, IL, United States, 3 510(k) clearances
Endoplus is registered with the FDA (registration 1423714) in Mundelein, IL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1423714
- FEI number
- 3000719482
- Address
- 750 Tower Rd Ste A, Mundelein, IL, United States, 60060
- Owner or operator
- ENDOPLUS (9005786)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- Endoplus Hand-held Laparoscopic Instruments, Reusable laparoscopic devices, inserts, handle and tube assemblies, coagulators, scissors, forceps, Reusable laparoscopic devices, inserts, handle and tube assy, scissors, forceps, knot pushers, probes, luer caps & ports, Ruggles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coagulator, Culdoscopic (And Accessories) | HFI | 2 | Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2015 | K151567 | ENDOPLUS hand-held laparoscopic instruments | HFI | Substantially Equivalent | Endoplus | accessdata.fda.gov |
| August 24, 1994 | K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | HET | Substantially Equivalent | Endo Technic Corp. | accessdata.fda.gov |
| February 28, 1994 | K925114 | LAPAROSCOPIC INSTRUMENTS | HFI | Substantially Equivalent | Endo Technic Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 15, 2013 | 66063 | Class II | Terminated | ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, di | Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of Coagulator, Culdoscopic (And Accessories)
- All makers of Drills, Burrs, Trephines & Accessories (Manual)
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 23, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.