STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K-Number: K192580 · 2019-12-18
ApplicantETHICON, Inc.
Decision Date2019-12-18
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2019-12-18 under approval number K192580. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by ETHICON, Inc.. The 510(k) number is K192580.
When was STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device approved by the FDA?
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device received FDA 510(k) clearance on 2019-12-18, under approval number K192580.
What company makes STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is manufactured by ETHICON, Inc..
What is the FDA product code for STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?
The FDA product code for STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is GAM.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.