FDA 510(k)

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

K-Number: K252743 · 2025-12-22

Decision Date2025-12-22

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K252743. 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 PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by ETHICON, Inc.. The 510(k) number is K252743.

When was STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device approved by the FDA?

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device received FDA 510(k) clearance on 2025-12-22, under approval number K252743.

What company makes STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is manufactured by ETHICON, Inc..

What is the FDA product code for STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device?

The FDA product code for STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is GAM.

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Related Devices (Code: GAM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.