ADVACOAT SINUS GEL AND STENT— 510(k) K070496

Name: FDA 510(k) clearance K070496
Creator: U.S. Food and Drug Administration
Published: 2007-03-15

Substantially Equivalent

Carbylan Biosurgery

FDA 510(k) clearance K070496 for ADVACOAT SINUS GEL AND STENT, Substantially Equivalent on 2007-03-15. Applicant: Carbylan Biosurgery. Device class: 1.

Clearance details

Applicant: Carbylan Biosurgery
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2007-02-20
Decision date: 2007-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYA

view all

K243655 — TurbAlign2025-07-11
K230142 — Epi-Stop Nasal Gel/epistaxis pack2023-03-22
K213153 — SPIWay Endonasal Access Guide2021-10-27
K202623 — Novapak Nasal Sinus Packing and Stent2020-12-08
K181696 — ChitoZolve2018-11-30

More clearances from Carbylan Biosurgery

view all

K063308 — ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 92002006-12-04

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