MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL— 510(k) K122434

Name: FDA 510(k) clearance K122434
Creator: U.S. Food and Drug Administration
Published: 2012-10-31

Substantially Equivalent

Medtronic Xomed

FDA 510(k) clearance K122434 for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL, Substantially Equivalent on 2012-10-31. Applicant: Medtronic Xomed. Device class: 2.

Clearance details

Applicant: Medtronic Xomed
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2012-08-10
Decision date: 2012-10-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Jacksonville, FL, 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
K210411 — PosiSep EAR Fragmentable Ear Dressing2022-05-05

More clearances from Medtronic Xomed

view all

K202623 — Novapak Nasal Sinus Packing and Stent2020-12-08
K031510 — NIM-SPINE2003-06-18
K002972 — MEROGEL CONTROL GEL ENT SURGICAL DRESSING2000-12-15
K002224 — XPS 3000 SYSTEM2000-12-04
K000728 — MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE2000-03-21

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