TRUCLEAR Operative Hysteroscope 5C And Sheath 5C

Hysteroscope (and Accessories)

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Truclear Operative Hysteroscope 5c And Sheath 5c.

Pre-market Notification Details

Device IDK152143
510k NumberK152143
Device Name:TRUCLEAR Operative Hysteroscope 5C And Sheath 5C
ClassificationHysteroscope (and Accessories)
Applicant SMITH & NEPHEW, INC. 150 Minuteman Road Andover,  MA  01810
ContactBradley Heil
CorrespondentBradley Heil
SMITH & NEPHEW, INC. 150 Minuteman Road Andover,  MA  01810
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-03
Decision Date2015-09-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556583685 K152143 000
00885556583654 K152143 000
10884521746695 K152143 000
10884521746688 K152143 000
10884521746756 K152143 000
10884521744134 K152143 000

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