ClearanceBrief
Company ยท US

Domain Surgical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2015. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEIElectrosurgical, Cutting & Coagulation & Accessories5
HGIElectrocautery, Gynecologic (And Accessories)2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 2, 2015K142229Laparoscopic FMsealer
Domain Surgical, Inc.
GEI
Jul 30, 2014K141484OPEN FMSEALER
Domain Surgical, Inc.
GEI
May 23, 2014K140384FMWAND HANDPIECE SE
Domain Surgical, Inc.
GEI
Jan 3, 2014K130606FMWAND FERROMAGNETIC SURGICAL SYSTEM
Domain Surgical, Inc.
HGI
Oct 18, 2012K121881DOMAIN SURGICAL SYSTEM
Domain Surgical, Inc.
HGI
Jul 18, 2011K110439DOMAIN SURGICAL SYSTEM
Domain Surgical, Inc.
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 1, 2016Domain Surgical, Inc.
FMsealer Open Shears. Model FM3001
Terminated		 GEIK141484
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