Summit Medical, Inc.
Summit Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2018, with 3 FDA device recalls on record.
Top product codes for Summit Medical, Inc.
FDA recalls by Summit Medical, Inc.
- Z-0435-2016 — AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
- Z-1731-2014 — Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
- Z-1319-2013 — Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Summit Medical, Inc.
- K180528 — InstruSafe(R) Sterilization Container
- K162046 — MINNE TIES MMF Suture System
- K151166 — Instru-Safe Instrument Protection System
- K150540 — Instru-Safe Instrument Protection System
- K142768 — Instru-Safe Instrument Protection System
- K142630 — Instru-Safe Instrument Protection System
- K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
- K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
- K133015 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.