Stereotactic Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Stereotactic Medical Systems, Inc. makes
Stereotactic Medical Systems, Inc. manufactures infusion pumps, including the EP-100 series, designed for controlled drug delivery. The company also produces stereotactic systems for neurosurgical procedures, such as the COMPASS™ stereotactic retractor and positioning systems, along with CT stereotactic adaptation tools for imaging-guided interventions.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States, where its products are registered for commercial distribution.
Catalogue
Ep-100 Infusion Pump Ref K883653
Regimes: 510(k) Registry: 510(k)Compass(Tm) Stereotactic Retractor System Ref K896156
Regimes: 510(k) Registry: 510(k)Compass Stereotactic Positioning System Ref K871046
Regimes: 510(k) Registry: 510(k)Ep-100 (Series) Ref K884415
Regimes: 510(k) Registry: 510(k)Compass Ct Stereotactic Adaptation System Ref K862220
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stereotactic Medical Systems, Inc. have in the registry?
The registry currently lists 5 devices for Stereotactic Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stereotactic Medical Systems, Inc.'s devices?
Among its 5 most recently registered devices, Stereotactic Medical Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Stereotactic Medical Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Stereotactic Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stereotactic Medical Systems, Inc. in the registry?
The most recently registered devices listed for Stereotactic Medical Systems, Inc. include EP-100 INFUSION PUMP, COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM, COMPASS STEREOTACTIC POSITIONING SYSTEM and EP-100 (SERIES).