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FDA 510(k)

PRONOVA NONABSORBABLE SUTURE, USP

K-Number: K001625 · 2000-07-10

ApplicantETHICON, Inc.
Decision Date2000-07-10
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRONOVA NONABSORBABLE SUTURE, USP is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2000-07-10 under 510(k) number K001625. 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 PRONOVA NONABSORBABLE SUTURE, USP?

PRONOVA NONABSORBABLE SUTURE, USP is a medical device that received FDA 510(k) clearance on 2000-07-10. The listed applicant is ETHICON, Inc.. The 510(k) number is K001625.

When did PRONOVA NONABSORBABLE SUTURE, USP receive FDA 510(k) clearance?

PRONOVA NONABSORBABLE SUTURE, USP received FDA 510(k) clearance on 2000-07-10, under 510(k) number K001625.

Who is the listed applicant for PRONOVA NONABSORBABLE SUTURE, USP?

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 PRONOVA NONABSORBABLE SUTURE, USP?

The FDA product code for PRONOVA NONABSORBABLE SUTURE, USP is GAW.

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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.

K253394Coated 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 DeviceK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureK252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceK243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

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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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