FDA 510(k)

NEZHAT-DORESEY PENCIL-GRIP HANDLES

K-Number: K951732 · 1995-05-24

ApplicantAmerican Hydro-Surgical Instruments, Inc.

Decision Date1995-05-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEZHAT-DORESEY PENCIL-GRIP HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is American Hydro-Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K951732. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEZHAT-DORESEY PENCIL-GRIP HANDLES?

NEZHAT-DORESEY PENCIL-GRIP HANDLES is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is American Hydro-Surgical Instruments, Inc.. The 510(k) number is K951732.

When did NEZHAT-DORESEY PENCIL-GRIP HANDLES receive FDA 510(k) clearance?

NEZHAT-DORESEY PENCIL-GRIP HANDLES received FDA 510(k) clearance on 1995-05-24, under 510(k) number K951732.

Who is the listed applicant for NEZHAT-DORESEY PENCIL-GRIP HANDLES?

The FDA 510(k) record lists American Hydro-Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEZHAT-DORESEY PENCIL-GRIP HANDLES?

The FDA product code for NEZHAT-DORESEY PENCIL-GRIP HANDLES is GEI.

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Other records listing American Hydro-Surgical Instruments, Inc. as applicant

K953574NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER K953481NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER K952070NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS K946380NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)K951300NEZHAT-DORSEY THERMAL RETENTION SYSTEM K950499NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS

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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.