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FDA 510(k)

SCHURING OSSICLE CUP & COLUMELLA PROSTH.

K-Number: K802431 · 1980-11-12

ApplicantRichard'S Medical Equip., Inc.
Decision Date1980-11-12
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SCHURING OSSICLE CUP & COLUMELLA PROSTH. is the device name listed in this FDA 510(k) record. The listed applicant is Richard'S Medical Equip., Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802431. 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 SCHURING OSSICLE CUP & COLUMELLA PROSTH.?

SCHURING OSSICLE CUP & COLUMELLA PROSTH. is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K802431.

When did SCHURING OSSICLE CUP & COLUMELLA PROSTH. receive FDA 510(k) clearance?

SCHURING OSSICLE CUP & COLUMELLA PROSTH. received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802431.

Who is the listed applicant for SCHURING OSSICLE CUP & COLUMELLA PROSTH.?

The FDA 510(k) record lists Richard'S Medical Equip., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCHURING OSSICLE CUP & COLUMELLA PROSTH.?

The FDA product code for SCHURING OSSICLE CUP & COLUMELLA PROSTH. is ETB.

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Other records listing Richard'S Medical Equip., Inc. 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.

K830793PATIENT GUIDED ELBOW & SHOULDER EXERCK823837RMC TOTAL KNEE SYSTEMK823723SPECTRON PROXIMAL FEMORAL PROSTHESISK823724SPECTRON NECK REPLACEMENT PROSTHESISK823726SPECTRON CONVERSION ENDOPROSTHESIS CUPK823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHES

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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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