Data / Medical devices / Germany / Medineedle - Rescue Group Rettungsdienst
Medineedle - Rescue Group Rettungsdienst: FDA-registered device maker in Wolpertshausen Bavaria, Germany, 8 510(k) clearances
Medineedle - Rescue Group Rettungsdienst is registered with the FDA (registration 3021194552) in Wolpertshausen Bavaria, Germany. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 20, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021194552
- Address
- Bruckenstrabe 10, Wolpertshausen Bavaria, Germany, 74549
- Owner or operator
- Medineedle - Rescue Group Rettungsdienst (10057331)
- Roles
- Exporter to the US
- First device listed
- March 22, 2018
- Registered through
- 2027
- Brand names listed
- ABSORBATACK Absorbable Fixation Device, Bard Ventralex Hernia Patch, HARMONIC ACE Shears with advanced hemostasis, Ligaclip Endoscopic Rotating Multiple Clip Applier, Ligamax 5 clip applier, Securestrap 5mm absorbable strap fixation device, The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reload, Tri-Staple 2 Reinforced Reload
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Implantable | FZP | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Exporter to the US | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| February 20, 2018 | K173270 | Tri-Staple 2.0 Reinforced Reload | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 10, 2015 | K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 22, 2014 | K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 17, 2013 | K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| April 7, 2010 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Implantable
- All makers of Mesh, Surgical, Polymeric
- All makers of Instrument, Ultrasonic Surgical
- All makers of Clip, Implantable
- All makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
Updated February 20, 2018. 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.