Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device clamp, circumcision
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHFX
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1
BIONX
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 5
Detachment of device component 2
Unknown (for use when the device problem is not known) 2
Malfunction 1
Failure to cut 1
Device, removal of (non-implant) 1
Device operates differently than expected 1
Loose 1
Misassembled 1
Slippage of device or device component 1
Use of Device Issue 1
Total Device Problems 17

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Deroyal Industries, Inc. Lafollette II Sep-16-2011
2 Surgical Design Inc II May-06-2011

-
-