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FDA 510(k)

REVISED LABELING FOR POLYPROPYLENE SUTURE

K-Number: K926588 · 1993-12-17

ApplicantLook, Inc.
Decision Date1993-12-17
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVISED LABELING FOR POLYPROPYLENE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Look, Inc.. It received FDA 510(k) clearance on 1993-12-17 under 510(k) number K926588. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVISED LABELING FOR POLYPROPYLENE SUTURE?

REVISED LABELING FOR POLYPROPYLENE SUTURE is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Look, Inc.. The 510(k) number is K926588.

When did REVISED LABELING FOR POLYPROPYLENE SUTURE receive FDA 510(k) clearance?

REVISED LABELING FOR POLYPROPYLENE SUTURE received FDA 510(k) clearance on 1993-12-17, under 510(k) number K926588.

Who is the listed applicant for REVISED LABELING FOR POLYPROPYLENE SUTURE?

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

What is the FDA product code for REVISED LABELING FOR POLYPROPYLENE SUTURE?

The FDA product code for REVISED LABELING FOR POLYPROPYLENE SUTURE is GAW.

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Other records listing Look, 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.

K943949POLYVIOLENE SURGICL SUTUREK933686LOOK INC. 316L STAINLESS STEEL SURGICAL SUTUREK926586REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURESK926168SILK SUTURES-REVISED LABELINGK926167POLYVIOLENE SUTURE-REVISED LABELINGK926587REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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