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FDA 510(k)

INSTRUMED RETRACTORS

K-Number: K071771 · 2007-08-02

ApplicantInstrumed International, Inc.
Decision Date2007-08-02
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSTRUMED RETRACTORS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed International, Inc.. It received FDA 510(k) clearance on 2007-08-02 under 510(k) number K071771. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMED RETRACTORS?

INSTRUMED RETRACTORS is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is Instrumed International, Inc.. The 510(k) number is K071771.

When did INSTRUMED RETRACTORS receive FDA 510(k) clearance?

INSTRUMED RETRACTORS received FDA 510(k) clearance on 2007-08-02, under 510(k) number K071771.

Who is the listed applicant for INSTRUMED RETRACTORS?

The FDA 510(k) record lists Instrumed International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTRUMED RETRACTORS?

The FDA product code for INSTRUMED RETRACTORS is GZT.

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Other records listing Instrumed International, 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.

K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXK092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALK092544INSTRUMED VASCULAR CLAMPSK081651INSTRUMED RONGEURK040855INSTRUMED LAPAROSCOPE AND ACCESSORIES

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Related Devices (Code: GZT)

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K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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.

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