Spiess Design, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Spiess Design, Inc. makes
Spiess Design, Inc. manufactures surgical insufflation and irrigation devices, including the HydroDissector for tissue separation, the CO₂ Insufflator for high-flow gas delivery, the Safety Trocar with an obdurator mechanism for controlled tissue penetration, and the Delta Pump for precise fluid management in minimally invasive procedures.
The company’s portfolio consists of Class II medical devices, all of which are subject to 510(k) clearance through the FDA. These devices are listed under the US regulatory framework, and the manufacturer is based in the United States.
Catalogue
Hydrodisector Ref K914177
Regimes: 510(k) Registry: 510(k)CO2 Insufflator High Flow Electronic Insufflator Ref K920114
Regimes: 510(k) Registry: 510(k)Safety Trocer With Springloaded Obdurator Ref K960347
Regimes: 510(k) Registry: 510(k)Delta Pump Ref K790814
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spiess Design, Inc. have in the registry?
The registry currently lists 4 devices for Spiess Design, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spiess Design, Inc.'s devices?
Among its 4 most recently registered devices, Spiess Design, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Spiess Design, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Spiess Design, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spiess Design, Inc. in the registry?
The most recently registered devices listed for Spiess Design, Inc. include HYDRODISECTOR, CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR, SAFETY TROCER WITH SPRINGLOADED OBDURATOR and DELTA PUMP.