Atlas FDA

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device

FDA 510(k) clearance K192580 · decided 2019-12-18

Clearance details

K-number
K192580
Device name
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
Applicant
ETHICON, Inc.
Decision
Substantially Equivalent
Date received
2019-09-19
Decision date
2019-12-18
Days to decision
90 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
Somerville, NJ, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPI recall (Z-1533-2024)Ethicon, Inc.2024-04-12

PMA approvals by this applicant

RecordFirmDate
ETHIZIA (P240035)ETHICON, Inc.2025-12-15
INTERCEED™ Absorbable Adhesion Barrier (P880047/S068)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S127)ETHICON, Inc.2025-12-12
SURGICEL® Absorbable Hemostats (N12159/S122)ETHICON, Inc.2025-11-04
SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126)ETHICON, Inc.2025-10-09
GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067)ETHICON, Inc.2025-10-09
SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125)ETHICON, Inc.2025-09-24
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S066)ETHICON, Inc.2025-09-24