Omni-Tract Surgical, Div. Minn. Scientific, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Omni-Tract Surgical, Div. Minn. Scientific, Inc. makes
Omni-Tract Surgical manufactures surgical instruments for minimally invasive and open procedures, including devices for vascular access such as an intraluminal artery stripper, as well as retractors for abdominal wall and MRI-compatible applications. Their portfolio also includes the MASS Micro-Access Spine System, designed for spinal interventions requiring precise micro-access techniques.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions documented through 510(k) clearances. These products are listed under the FDA’s regulatory framework and are developed by Omni-Tract Surgical, a division of Minnesota Scientific, Inc., based in the United States.
Catalogue
Intraluminal Artery Stripper Ref K913803
Regimes: 510(k) Registry: 510(k)Abdominal Wall Retractor Ref K950214
Regimes: 510(k) Registry: 510(k)Mri Fastsystem Retractor System Ref K001339
Regimes: 510(k) Registry: 510(k)Mass (Micro-Access Spine System) Ref K992583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omni-Tract Surgical, Div. Minn. Scientific, Inc. have in the registry?
The registry currently lists 4 devices for Omni-Tract Surgical, Div. Minn. Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omni-Tract Surgical, Div. Minn. Scientific, Inc.'s devices?
Among its 4 most recently registered devices, Omni-Tract Surgical, Div. Minn. Scientific, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Omni-Tract Surgical, Div. Minn. Scientific, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Omni-Tract Surgical, Div. Minn. Scientific, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omni-Tract Surgical, Div. Minn. Scientific, Inc. in the registry?
The most recently registered devices listed for Omni-Tract Surgical, Div. Minn. Scientific, Inc. include INTRALUMINAL ARTERY STRIPPER, ABDOMINAL WALL RETRACTOR, MRI FASTSYSTEM RETRACTOR SYSTEM and MASS (MICRO-ACCESS SPINE SYSTEM).