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FDA 510(k)

NON-STERILE SUTURE NEEDLES

K-Number: K881394 · 1988-04-08

ApplicantChina National Medicines C/O Havel'S
Decision Date1988-04-08
Product CodeGDL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE SUTURE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is China National Medicines C/O Havel'S. It received FDA 510(k) clearance on 1988-04-08 under 510(k) number K881394. The device is classified under product code GDL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-STERILE SUTURE NEEDLES?

NON-STERILE SUTURE NEEDLES is a medical device that received FDA 510(k) clearance on 1988-04-08. The listed applicant is China National Medicines C/O Havel'S. The 510(k) number is K881394.

When did NON-STERILE SUTURE NEEDLES receive FDA 510(k) clearance?

NON-STERILE SUTURE NEEDLES received FDA 510(k) clearance on 1988-04-08, under 510(k) number K881394.

Who is the listed applicant for NON-STERILE SUTURE NEEDLES?

The FDA 510(k) record lists China National Medicines C/O Havel'S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE SUTURE NEEDLES?

The FDA product code for NON-STERILE SUTURE NEEDLES is GDL.

Related Clinical Trials

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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: GDL)

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.

K85178225-450 TO 25-540 VARIOUS SUTURE FORCEPSArtiberiaK85178125-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLESArtiberiaK813589SHARTPOINT EYED NEEDLESS. Jackson, Inc.K812566UNIVERSAL SUTURE PASSEROrtho Pared Instruments, Inc.

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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