510(k) Report

FDA applicant

Obtech Medical GmbH

Zug2 decisions2007–200719 recalls

FDA records 2 decisions for Obtech Medical GmbH (Zug) in 2007: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LTI (Implant, Intragastric For Morbid Obesity) and KNT (Tubes, Gastrointestinal (And Accessories)). 19 recalls are linked to its devices.

FDA’s records also spell it “Obtech Medical Sarl”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Obtech Medical GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2013

2010: 162013: 3
2007high 16 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Obtech Medical GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Obtech Medical GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LTIImplant, Intragastric For Morbid Obesity1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071764Realize Gastric Calibration Tube, Models GCT180, GCT360Obtech Medical Sarl · 20073cite it

What has FDA decided for it lately?

  • K071764Realize Gastric Calibration Tube, Models GCT180, GCT360Obtech Medical Sarl · 2007
  • P070009Realize Adjustable Gastric Band Model 2200-XObtech Medical GmbH · 200719 recalls

The one decision as Obtech Medical GmbH →The one decision as Obtech Medical Sarl →

What has been recalled?

19 recalls linked to its devices; the latest:

  • P070009Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…Sep 30, 2013Class II
  • P070009Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…Sep 30, 2013Class II
  • P070009Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…Sep 30, 2013Class II
  • P070009REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22…Sep 27, 2010
  • P070009REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot…Sep 27, 2010
  • P070009REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar…Sep 27, 2010