South Mountain Medical
Country not established
- Devices
- 7
What South Mountain Medical makes
South Mountain Medical produces single-use surgical textiles and sterile wound care supplies, including surgical masks, gauze sponges, Huck towels, laparotomy pads, and sterile suture kits processed with gamma radiation. Their portfolio also includes disposable surgical drapes (Action PAC) and a disposable suture removal device (Sure Snip).
The company’s devices are regulated under FDA Class I and Class II classifications, with some falling under the exempt Class U category. Products are listed via the FDA’s 510(k) pathway, and the manufacturer operates from the United States.
Catalogue
Surgical Mask Ref K812992
Regimes: 510(k) Registry: 510(k)Gauze Sponge Ref K853742
Regimes: 510(k) Registry: 510(k)Huck Towel Ref K852945
Regimes: 510(k) Registry: 510(k)Laparotomy Pads Ref K811769
Regimes: 510(k) Registry: 510(k)Action Pac Ref K851276
Regimes: 510(k) Registry: 510(k)Suture Kits Sterilized W/Gama Radiation Ref K831806
Regimes: 510(k) Registry: 510(k)Sure Snip Ref K823485
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does South Mountain Medical have in the registry?
The registry currently lists 7 devices for South Mountain Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list South Mountain Medical's devices?
Among its 7 most recently registered devices, South Mountain Medical has devices listed in FDA 510(k) (7 devices).
What risk classes do South Mountain Medical's devices fall under?
Among its 7 most recently registered devices, the classes recorded for South Mountain Medical's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from South Mountain Medical in the registry?
The most recently registered devices listed for South Mountain Medical include SURGICAL MASK, GAUZE SPONGE, HUCK TOWEL and LAPAROTOMY PADS.