FDA.reportPublic FDA data

Device Listing 1601899810

Listing Summary#

Listing key
1601899810
Premarket submission
K112584
Device
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
Applicant
Intuitive Surgical, Inc.
Product code
NAY
Decision date
2011-09-29