SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS— 510(k) K033554

Name: FDA 510(k) clearance K033554
Creator: U.S. Food and Drug Administration
Published: 2003-11-24

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K033554 for SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS, Substantially Equivalent on 2003-11-24. Applicant: Gyrus Ent LLC. Device class: 2.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ETB
Device class: Class 2
Regulation: 21 CFR 874.3450
Advisory panel: Ear, Nose, Throat
Date received: 2003-11-12
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETB

view all

K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more2026-04-03
K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more2026-04-03
K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis2025-01-17
K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit2025-01-17
K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS2013-12-02

More clearances from Gyrus Ent LLC

view all

K040996 — RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM2004-08-20
K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE2004-03-03
K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM2004-02-05
K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE2003-05-02
K021595 — GYRUS ENT NERVE STIMULATOR2002-10-24

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