FDA 510(k)

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

K-Number: K011115 · 2001-05-02

Decision Date2001-05-02

Product CodeMML

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 is the device name listed in this FDA 510(k) record. The listed applicant is Heinz Kurz GmbH Medizintechnik. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K011115. The device is classified under product code MML. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010?

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K011115.

When did KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 receive FDA 510(k) clearance?

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 received FDA 510(k) clearance on 2001-05-02, under 510(k) number K011115.

Who is the listed applicant for KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010?

The FDA 510(k) record lists Heinz Kurz GmbH Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010?

The FDA product code for KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 is MML.

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Other records listing Heinz Kurz GmbH Medizintechnik as applicant

K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS K071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM K033796KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

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Related Devices (Code: MML)

K170591Altomed Malhotra Platinum SegmentsAltomed Limited K021750LID CHAIN EYELID WEIGHTSJedmed Instrument Co.K011740CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)Meddev Corp.K003646SUTUREGROOVE WEIGHT SIZING SETIop, Inc.K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH Medizintechnik K994289SUTUREGROOVEIop, Inc.

Official Source

View on FDA Database →

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