REVEEL ENDOSCOPIC RETRACTOR

Laparoscope, General & Plastic Surgery

RETRACTION LIMITED

The following data is part of a premarket notification filed by Retraction Limited with the FDA for Reveel Endoscopic Retractor.

Pre-market Notification Details

Device IDK133345
510k NumberK133345
Device Name:REVEEL ENDOSCOPIC RETRACTOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant RETRACTION LIMITED UNIT F, 2/F, HONG KONG INDUSTRIAL BLDG 444-452 DES VOEUX ROAD WEST Sai Wan, Hong Kong,  CN 999077
ContactStuart Moran
CorrespondentStuart Moran
RETRACTION LIMITED UNIT F, 2/F, HONG KONG INDUSTRIAL BLDG 444-452 DES VOEUX ROAD WEST Sai Wan, Hong Kong,  CN 999077
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-30
Decision Date2014-04-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811099014423 K133345 000
00811099014393 K133345 000

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