SMITH & NEPHEW PISTONS— 510(k) K003214
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K003214 for SMITH & NEPHEW PISTONS, Substantially Equivalent on 2000-10-31. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Recent devices under product code ETB
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- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
More clearances from Gyrus Ent LLC
view all- K040996 — RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
- K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
- K033089 — HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
- K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
- K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
Recalls naming K003214
K-number listed on FDA's recall record- Z-2813-2020 — Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- Z-2814-2020 — Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003214.
Data sourced from openFDA. This site is unofficial and independent of the FDA.