Atlas FDA

MONOFILAMENT BIOSYN SUTURE

FDA 510(k) clearance K000037 · decided 2000-03-30

Clearance details

K-number
K000037
Device name
MONOFILAMENT BIOSYN SUTURE
Applicant
United States Surgical, A Division of Tyco Healthc
Decision
Substantially Equivalent
Date received
2000-01-06
Decision date
2000-03-30
Days to decision
84 days
Clearance type
Traditional
Product code
GAM
Device class
2
Regulation number
878.4493
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Norwalk, CT, US
Third-party review
No
Expedited review
No

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Monotime and Optime R (K233265)Peters Surgical2024-10-11
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Recalls involving this device

RecordFirmDate
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product recall (Z-1274-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: I recall (Z-1275-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: I recall (Z-1276-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: I recall (Z-1277-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Ind recall (Z-1278-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: recall (Z-1279-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: In recall (Z-1280-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Ind recall (Z-1281-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Ind recall (Z-1282-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: recall (Z-1283-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Ind recall (Z-1284-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: recall (Z-1285-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: I recall (Z-1286-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Ind recall (Z-1287-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product U recall (Z-1288-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: I recall (Z-1289-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: recall (Z-1290-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage recall (Z-1291-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Us recall (Z-1292-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: recall (Z-1293-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indic recall (Z-1294-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indic recall (Z-1295-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: recall (Z-1296-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: I recall (Z-1297-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: In recall (Z-1298-2020)Covidien LLC2020-02-19
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: I recall (Z-1299-2020)Covidien LLC2020-02-19
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 recall (Z-1300-2020)Covidien LLC2020-02-19