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FDA 510(k)

UNIVERSAL SUTURE PASSER

K-Number: K812566 · 1981-11-10

ApplicantOrtho Pared Instruments, Inc.
Decision Date1981-11-10
Product CodeGDL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL SUTURE PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pared Instruments, Inc.. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K812566. 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 UNIVERSAL SUTURE PASSER?

UNIVERSAL SUTURE PASSER is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Ortho Pared Instruments, Inc.. The 510(k) number is K812566.

When did UNIVERSAL SUTURE PASSER receive FDA 510(k) clearance?

UNIVERSAL SUTURE PASSER received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812566.

Who is the listed applicant for UNIVERSAL SUTURE PASSER?

The FDA 510(k) record lists Ortho Pared Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL SUTURE PASSER?

The FDA product code for UNIVERSAL SUTURE PASSER is GDL.

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 Ortho Pared Instruments, 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.

K831772GUILLOTINE BLADEK820225MENISCUS EXTRACTORK820226UNIVERSALL DRILL GUIDE

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.

K881394NON-STERILE SUTURE NEEDLESChina National Medicines C/O Havel'SK85178225-450 TO 25-540 VARIOUS SUTURE FORCEPSArtiberiaK85178125-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLESArtiberiaK813589SHARTPOINT EYED NEEDLESS. Jackson, 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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