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510(k) Data Aggregation
K Number
K972703Device Name
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
Manufacturer
B. BRAUN MEDICAL, INC.
Date Cleared
1997-10-01
(75 days)
Product Code
GCY
Regulation Number
878.4680Why did this record match?
Product Code :
GCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.
Device Description
REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.
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K Number
K971036Device Name
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
Manufacturer
INTERPORE INTL.
Date Cleared
1997-06-03
(75 days)
Product Code
GCY
Regulation Number
878.4680Why did this record match?
Product Code :
GCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
Device Description
The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.
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K Number
K963839Device Name
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
Manufacturer
CORDIS CORP.
Date Cleared
1996-12-12
(79 days)
Product Code
GCY
Regulation Number
878.4680Why did this record match?
Product Code :
GCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections.
Device Description
The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.
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K Number
K960099Device Name
PENROSE DRAIN MODELS 6001 - 6007
Manufacturer
SIL-MED CORP.
Date Cleared
1996-03-11
(60 days)
Product Code
GCY
Regulation Number
878.4680Why did this record match?
Product Code :
GCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
Device Description
Passive Wound Drain. Flat Silicone Drain. Dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Sil-Med Penrose Drains are sold sterile only.
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