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FDA 510(k)

GRAMS SILK NONABSORBABLE SUTURE

K-Number: K003001 · 2000-12-15

ApplicantGramsmed, LLC
Decision Date2000-12-15
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAMS SILK 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 2000-12-15 under 510(k) number K003001. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAMS SILK NONABSORBABLE SUTURE?

GRAMS SILK NONABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Gramsmed, LLC. The 510(k) number is K003001.

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

GRAMS SILK NONABSORBABLE SUTURE received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003001.

Who is the listed applicant for GRAMS SILK 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 SILK NONABSORBABLE SUTURE?

The FDA product code for GRAMS SILK NONABSORBABLE SUTURE is GAP.

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 SUTUREK002999GRAMS POLYPROPYLENE NONABSORBABLE SUTUREK003000GRAMS NYLON NONABSORBABLE SUTURE

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Related Devices (Code: GAP)

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.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/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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