SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE— 510(k) K992839
Substantially EquivalentHeinz Kurz GmbH Medizintechnik
FDA 510(k) clearance K992839 for SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE, Substantially Equivalent on 1999-09-16. Applicant: Heinz Kurz GmbH Medizintechnik. Device class: 2.
Clearance details
- Applicant
- Heinz Kurz GmbH Medizintechnik
- 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
- Amsterdam, Nh, NL
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 Heinz Kurz GmbH Medizintechnik
view all- K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
- K071150 — TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
- K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
- K033796 — KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
- K021479 — CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
Data sourced from openFDA. This site is unofficial and independent of the FDA.