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510(k) Data Aggregation
K Number
K012198Device Name
GIBBONS STERILE TROCAR KITS
Manufacturer
GIBBONS SURGICAL CORP.
Date Cleared
2001-08-09
(27 days)
Product Code
FBQ
Regulation Number
876.5090Why did this record match?
Product Code :
FBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
Device Description
Not Found
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K Number
K980804Device Name
SABRE BT BLUNT0TIP SURGICAL TROCAR
Manufacturer
ENDOSCOPIC CONCEPTS, INC.
Date Cleared
1998-04-01
(30 days)
Product Code
FBQ
Regulation Number
876.5090Why did this record match?
Product Code :
FBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.
Device Description
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.
Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.
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