Class Class U
S.E.A.L. Hemostatic Wound Spray (K210751)
Description
S.E.A.L. Hemostatic Wound Spray by Bc3 Technologies, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK210751
Clearance Date2023-02-02
Clearance TypeTraditional
Product CodeQSY
FDA Database
View on FDA DatabasePredicate lineage for K210751
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. S.E.A.L. Hemostatic Wound Spray (K210751) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K061079 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRA... | Medtrade Products , Ltd. | 2006 |
| K010933 | SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY | Alltracel Pharma , Ltd. | 2002 |
Trace the full predicate network for K210751
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.