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510(k) Data Aggregation
K Number
K243399Device Name
Boehringer Laboratories Liver Retractor
Manufacturer
Boehringer Laboratories, LLC
Date Cleared
2025-07-02
(244 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Boehringer Laboratories, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K150781Device Name
Tissue Removal Pouch
Manufacturer
BOEHRINGER LABORATORIES, LLC
Date Cleared
2015-06-19
(86 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BOEHRINGER LABORATORIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.
The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.
The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Device Description
The Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is provided sterile and is for single patient use.
The bag has a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation and removal from the patient. The bag opening is then exteriorized. The two halves of the flip ring are attached to each other and to the bag opening.
The bag is rolled around the flip ring by inverting the flip ring in order to draw the resected tissue toward the port site. The resected tissue is then removed en bloc (for smaller specimens) or by extracorporeal manual morcellation (for larger specimens). The guard may be used to protect the bag during manual morcellation. The bag is removed following the removal of sufficient tissue to be pulled out through the port site.
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K Number
K130483Device Name
BOEHRINGER GASTRIC SIZING TUBE
Manufacturer
BOEHRINGER LABORATORIES, LLC
Date Cleared
2013-03-28
(31 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
BOEHRINGER LABORATORIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Boehringer Laboratories Gastric Sizing Tube is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.
Device Description
The Boehringer Laboratories Gastric Sizing Tube is a single patient use, non-sterile device which consists of a 76 cm long, thermoplastic elastomer (Styrene-Ethylene-Styrene) tube of either 32 French, 36 French, or 40 French diameter, with a low density polyethylene (LDPE) slide valve-connector at the proximal end of the tube. The tube has multiple holes and a rounded end, distal from the slide valve, and contains a stainless steel support spring inside the lumen of the tube at the distal end. The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The slide valve is used to switch between open for suction/irrigation and closed/vent. The tube serves as a sizing guide.
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