# K210411: PosiSep EAR Fragmentable Ear Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: May 5, 2022 after 448 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K972082 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070715: Nasopore Ear, Polyganics B.V., (2007) Summary page 5.

## Indications for use
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery: As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation. PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K210411
Methodology: https://510kreport.com/methodology