TruClear Elite Hysteroscope

Hysteroscope (and Accessories)

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Truclear Elite Hysteroscope.

Pre-market Notification Details

Device IDK180496
510k NumberK180496
Device Name:TruClear Elite Hysteroscope
ClassificationHysteroscope (and Accessories)
Applicant Covidien 60 Middletown Ave. North Haven,  CT  06473
ContactGail Yaeker-daunis
CorrespondentGail Yaeker-daunis
Covidien 60 Middletown Ave. North Haven,  CT  06473
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-26
Decision Date2018-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521767744 K180496 000
10884521767737 K180496 000
20884521750200 K180496 000
10884521746657 K180496 000
10884521746640 K180496 000
10884521746633 K180496 000
10884521746626 K180496 000

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