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Found 7 results
510(k) Data Aggregation
K Number
K221042Device Name
Renova RP Centesis Pump
Manufacturer
GI Supply, Inc.
Date Cleared
2023-04-19
(376 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GI Supply, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis.
The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
Device Description
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP® Tube Set and RenovaRP® Fluid Drainage Bags (provided separately from the pump) to remove fluid from the abdominal cavity for paracentesis, and pleural effusion from the thoracic cavity for thoracentesis.
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K Number
K202376Device Name
EverLift Submucosal Lifting Agent
Manufacturer
Gi Supply, Inc.
Date Cleared
2020-09-30
(41 days)
Product Code
PLL
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Gi Supply, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
Device Description
The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.
EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
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K Number
K191923Device Name
EverLift Submucosal Lifting Agent
Manufacturer
GI Supply
Date Cleared
2020-06-20
(338 days)
Product Code
PLL
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GI Supply
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
Device Description
The GI Supply EverLift™ Submucosal Lifting Agent is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle.
The EverLift™ Submucosal Lifting Agent is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
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K Number
K031360Device Name
GI SUPPLY BILIARY STENT
Manufacturer
GI SUPPLY
Date Cleared
2003-09-24
(147 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
GI SUPPLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GI Supply Biliary Stent is a disposable single-use device intended for use to temporarily by-pass obstructions in the biliary tree and allow drainage into the duodenum.
Device Description
The GI Supply Biliary Stent is a disposable single-use device.
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K Number
K012411Device Name
HP-ONE
Manufacturer
GI SUPPLY
Date Cleared
2001-09-25
(57 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
GI SUPPLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HP-ONE is for in-vitro diagnostic use only. It is intended to detect the urease enzyme of Helicobacter pylori and provide a presumptive diagnosis of H. pylori gastritis.
Device Description
HP-ONE detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. A gastric mucosal endoscopic biopsy is placed in the HP-ONE tray well and a reagent containing urea, hydrogen peroxide, a pH dye indicator, and an acidic buffer is placed over the biopsy specimen. A bubbling reaction occurs as catalase breaks down the peroxide. If H. pylori is present, the urease in H. pylori converts the urea to ammonia which raises the pH and changes the color of the reagent, indicating a positive test.
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K Number
K970186Device Name
GI SUPPLY PARACENTESIS PUMP
Manufacturer
GI SUPPLY
Date Cleared
1997-02-14
(28 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
GI SUPPLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970187Device Name
RUNYON LARGE VOLUME PARACENTESIS KIT
Manufacturer
GI SUPPLY
Date Cleared
1997-02-14
(28 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
GI SUPPLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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