Search Results
Found 7 results
510(k) Data Aggregation
K Number
K021043Device Name
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
Manufacturer
GRAMSMED LLC
Date Cleared
2002-06-21
(81 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
Ask a Question
K Number
K010672Device Name
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2001-05-18
(73 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003017Device Name
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2001-03-13
(167 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003590Device Name
GRAMS POLYESTER NONABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2001-03-05
(104 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K002999Device Name
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2000-12-18
(83 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003000Device Name
GRAMS NYLON NONABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2000-12-18
(83 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003001Device Name
GRAMS SILK NONABSORBABLE SUTURE
Manufacturer
GRAMSMED LLC
Date Cleared
2000-12-15
(80 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
GRAMSMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1