# K083354: Floraseal, Model FS350D

- Pathway: 510(k) (Abbreviated)
- Applicant: Adhezion Biomedical
- Decided: Jul 20, 2009 after 249 days
- Product code: NZP (Sealant, Microbial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Integuseal Microbial Sealant: named in the summary without a submission number

## Most influential descendants
- K170505: SecurePortIV Catheter Securement Adhesive (2017), 1 descendant of its own
- K223669: SecurePortIV Advanced Catheter Securement Adhesive (2023), 0 descendants of its own

## Indications for use
Flora SealTM Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical. procedure.

Source page: https://510kreport.com/device/K083354
Methodology: https://510kreport.com/methodology