Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE

K-Number: K002999 · 2000-12-18

ApplicantGramsmed, LLC
Decision Date2000-12-18
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Gramsmed, LLC. It received FDA 510(k) clearance on 2000-12-18 under 510(k) number K002999. 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 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE?

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Gramsmed, LLC. The 510(k) number is K002999.

When did GRAMS POLYPROPYLENE NONABSORBABLE SUTURE receive FDA 510(k) clearance?

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE received FDA 510(k) clearance on 2000-12-18, under 510(k) number K002999.

Who is the listed applicant for GRAMS POLYPROPYLENE NONABSORBABLE SUTURE?

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

What is the FDA product code for GRAMS POLYPROPYLENE NONABSORBABLE SUTURE?

The FDA product code for GRAMS POLYPROPYLENE NONABSORBABLE SUTURE is GAW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gramsmed, LLC 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.

K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICK010672MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTUREK003017GRAMSORB SYNTHETIC ABSORBABLE SUTUREK003590GRAMS POLYESTER NONABSORBABLE SUTUREK003000GRAMS NYLON NONABSORBABLE SUTUREK003001GRAMS SILK NONABSORBABLE SUTURE

View all 7 devices →

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.

↑