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FDA 510(k)

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

K-Number: K955613 · 1995-12-22

ApplicantMisten Medical Corp.
Decision Date1995-12-22
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Misten Medical Corp.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K955613. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Misten Medical Corp.. The 510(k) number is K955613.

When did MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS receive FDA 510(k) clearance?

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS received FDA 510(k) clearance on 1995-12-22, under 510(k) number K955613.

Who is the listed applicant for MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

The FDA 510(k) record lists Misten Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS?

The FDA product code for MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS is ETB.

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Other records listing Misten Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962163MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILLK955616MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBEK955615MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS

Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)MED-EL Elektromedizinische Geräte GmbHK260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbHK241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbHK241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbHK130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH MedizintechnikK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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