ClearanceBrief
510(k) K000037 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

MONOFILAMENT BIOSYN SUTURE

ApplicantUnited States Surgical, A Division of Tyco Healthc, Norwalk CT, US
DecisionSubstantially Equivalent, Mar 30, 2000
ReceivedJan 6, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000037

DateFirm and productCodeLinked 510(k)
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovas
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovasc
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascu
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neu
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neu
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or
Terminated
GAMNone listed
Feb 19, 2020Covidien LLC
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Terminated
GAMNone listed
May 3, 2017Medtronic
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Terminated
GAMNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.