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)

OPHIRA MINI SLING SYSTEM

K-Number: K110420 · 2012-05-08

ApplicantPromedon S.A
Decision Date2012-05-08
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPHIRA MINI SLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Promedon S.A. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K110420. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHIRA MINI SLING SYSTEM?

OPHIRA MINI SLING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Promedon S.A. The 510(k) number is K110420.

When did OPHIRA MINI SLING SYSTEM receive FDA 510(k) clearance?

OPHIRA MINI SLING SYSTEM received FDA 510(k) clearance on 2012-05-08, under 510(k) number K110420.

Who is the listed applicant for OPHIRA MINI SLING SYSTEM?

The FDA 510(k) record lists Promedon S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHIRA MINI SLING SYSTEM?

The FDA product code for OPHIRA MINI SLING SYSTEM is PAH.

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: PAH)

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.

K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.K221874Altis Single Incision Sling SystemColoplast A/SK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc.K121562ALTIS SINGLE INCISION CLING SYSTEMColoplast A/SK123179AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLINGC.R. Bard, Inc.K121641MINIARC PRO SINGLE-INCISION SLING SYSTEMAmerican Medical Systems

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.

↑