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Found 5 results
510(k) Data Aggregation
K Number
K234149Device Name
MOLLI 2 System
Manufacturer
MOLLI Surgical, Inc.
Date Cleared
2024-09-26
(272 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MOLLI Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Device Description
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI 2 System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
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K Number
K240042Device Name
MOLLI 2 System
Manufacturer
MOLLI Surgical, Inc.
Date Cleared
2024-09-25
(264 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MOLLI Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Device Description
The MOLLI Systems (MOLLI System and MOLLI 2 System) are precision surgical marking and guidance systems for locating non-palpable lesions during surgery. The systems consist of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand/MOLLI 2 Wands), and a visualization tablet (MOLLI Tablet/MOLLI Tablet 2). The MOLLI Wand/MOLLI 2 Wand Family and MOLLI Tablet/MOLLI 2 Tablet constitute the system. The MOLLI System is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
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K Number
K231579Device Name
MOLLI 2
Manufacturer
MOLLI Surgical, Inc.
Date Cleared
2023-10-26
(148 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MOLLI Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Device Description
MOLLI 2 is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI 2 consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand 2), and a visualization tablet (MOLLI Tablet 2). The MOLLI 2 Wand and MOLLI 2 Tablet constitute the MOLLI 2 system. The MOLLI 2 is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
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K Number
K223107Device Name
MOLLI 2
Manufacturer
MOLLI Surgical, Inc
Date Cleared
2023-01-18
(110 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MOLLI Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Device Description
MOLLI 2 is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI 2 consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand 2), and a visualization tablet (MOLLI Tablet 2). The MOLLI Wand 2 and MOLLI Tablet 2 constitute the MOLLI 2 System. The MOLLI 2 System is intended for the nonimaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
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K Number
K210600Device Name
MOLLI
Manufacturer
MOLLI Surgical, Inc.
Date Cleared
2021-04-16
(46 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
MOLLI Surgical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI System), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Device Description
MOLLI is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand), and a visualization tablet (MOLLI Tablet). The MOLLI Marker is preloaded in the MOLLI Introducer. The MOLLI Wand and the MOLLI Tablet constitute the MOLLI System. The MOLLI System is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
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