PosiSep EAR Fragmentable Ear Dressing— 510(k) K210411

Name: FDA 510(k) clearance K210411
Creator: U.S. Food and Drug Administration
Published: 2022-05-05

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K210411 for PosiSep EAR Fragmentable Ear Dressing, Substantially Equivalent on 2022-05-05. Applicant: Hemostasis, LLC. Device class: 2.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2021-02-11
Decision date: 2022-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHB

view all

K260620 — SeptAlign (SPLN001)2026-07-30
K251790 — SeptAlign2026-01-16
K233569 — SeptAlign2024-03-22
K223167 — Spirair Nasal Septal Strap2023-08-17
K192661 — LATERA Absorbable Nasal Implant System2019-11-10

More clearances from Hemostasis, LLC

view all

K234131 — Resolv Endoscopic Hemostat System2024-07-26
K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint2022-11-14
K142348 — OsteoSeal Bone Hemostat2015-01-23
K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT2013-03-27
K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING2012-11-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.