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)

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

K-Number: K012124 · 2001-09-19

ApplicantJohnson & Johnson Medical (China) , Ltd.
Decision Date2001-09-19
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical (China) , Ltd.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012124. 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 MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP?

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Johnson & Johnson Medical (China) , Ltd.. The 510(k) number is K012124.

When did MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP receive FDA 510(k) clearance?

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012124.

Who is the listed applicant for MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP?

The FDA 510(k) record lists Johnson & Johnson Medical (China) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP?

The FDA product code for MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP 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

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.

↑