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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, single patient use, portable, nonpowered
Regulation Description Nonpowered, single patient, portable suction apparatus.
Product CodeGCY
Regulation Number 878.4680
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERITAGE MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 6
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 173
Air leak 147
Other (for use when an appropriate device code cannot be identified) 103
Tears, rips, holes in device, device material 78
Locking mechanism failure 61
Valve(s), failure of 24
Suction issue 24
Device inoperable 17
Unknown (for use when the device problem is not known) 12
Material perforation 10
Decrease in suction 7
Difficult to remove 6
Device, or device fragments remain in patient 5
Device operates differently than expected 4
Fracture 4
Fluid leak 3
Disconnection 3
Component(s), broken 3
Detachment of device component 3
Improper flow or infusion 3
Device, removal of (non-implant) 3
Detachment of device or device component 2
Device clogged 2
Material fragmentation 2
Occlusion within device 2
Tip breakage 2
Implant, removal of 2
Device Issue 1
Obstruction within device 1
Defective item 1
Defective component 1
Use of Device Issue 1
Product quality issue 1
Replace 1
Markings unclear 1
Dislodged 1
Elective removal 1
Explanted 1
Inaccurate flowrate 1
Crack 1
Disassembly 1
Blockage within device or device component 1
Loss of or failure to bond 1
Circuit Failure 1
No code available 1
Patient-device incompatibility 1
Total Device Problems 724

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 2 1 1 1 1 0 1 2 0
Class III 0 0 1 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Products, Inc. II Apr-07-2014
2 Aspen Surgical Products, Inc. III May-22-2009
3 EXP Pharmaceutical Services Corp II Jul-24-2015
4 Genico, Inc., dba Genicon II Jul-02-2009
5 Integra LifeSciences Corp. II Sep-28-2010
6 MicroAire Surgical Instruments, LLC II Jun-09-2012
7 Stryker Instruments Div. of Stryker Corporation II May-01-2015
8 Terumo Cardiovascular Systems Corporation II Apr-15-2011
9 Zimmer Inc. II Sep-19-2008
10 Zimmer Inc. II Apr-09-2008
11 Zimmer Surgical Inc III May-13-2015

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