MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST

FDA Device Registration & Listing · Wolpertshausen Bavaria, DE · Registration 3021194552

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021194552
FEI Number
3021194552
Entity Name
MEDINEEDLE - RESCUE GROUP RETTUNGSDIENST
City/State/Country
Wolpertshausen Bavaria, DE
Establishment Address
Bruckenstrabe 10, Wolpertshausen Bavaria 74549, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Medineedle - Rescue Group Rettungsdienst (Owner Number: 10057331)
Owner / Operator Contact Address
Bruckenstrabe 10, Wolpertshausen, DE-BY 74549, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K132612
PMA Number
N/A

All Registered Proprietary Names

The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reload Securestrap 5mm absorbable strap fixation device Ligaclip Endoscopic Rotating Multiple Clip Applier Bard Ventralex Hernia Patch Tri-Staple 2 Reinforced Reload Ligamax 5 clip applier HARMONIC ACE Shears with advanced hemostasis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-03-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-03-22
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2018-03-22
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-03-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2018-03-22
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2018-03-22
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2018-03-22
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-03-22

Official Correspondent

Marco Schelhorn

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Medineedle - Rescue Group Rettungsdienst
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22
K130717 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RELOAD 2013-04-18
K221006 Covidien GIA Stapler with Tri-Staple Technology 2022-04-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021 N/A 2
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021194552. Last updated year: 2026. Please use registration number 3021194552 when referencing this establishment in official correspondence.
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