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FDA 510(k)

Surgical Stainless Steel Suture, Stainless Steel Suture

K-Number: K170767 · 2017-11-01

ApplicantETHICON, Inc.
Decision Date2017-11-01
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Stainless Steel Suture, Stainless Steel Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K170767. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Stainless Steel Suture, Stainless Steel Suture?

Surgical Stainless Steel Suture, Stainless Steel Suture is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is ETHICON, Inc.. The 510(k) number is K170767.

When did Surgical Stainless Steel Suture, Stainless Steel Suture receive FDA 510(k) clearance?

Surgical Stainless Steel Suture, Stainless Steel Suture received FDA 510(k) clearance on 2017-11-01, under 510(k) number K170767.

Who is the listed applicant for Surgical Stainless Steel Suture, Stainless Steel Suture?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Stainless Steel Suture, Stainless Steel Suture?

The FDA product code for Surgical Stainless Steel Suture, Stainless Steel Suture is GAQ.

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Other records listing ETHICON, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA N12159Agent, absorbable hemostatic, non-collagen basedPMA P880047Barrier, absorbable, adhesionPMA P240035Agent, absorbable hemostatic, collagen with polymeric additivesK253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

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Related Devices (Code: GAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.

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.

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