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FDA 510(k)

NEEDLELESS SLING

K-Number: K063136 · 2006-12-19

ApplicantSpecialities Remeex International, S.L.
Decision Date2006-12-19
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEEDLELESS SLING is the device name listed in this FDA 510(k) record. The listed applicant is Specialities Remeex International, S.L.. It received FDA 510(k) clearance on 2006-12-19 under 510(k) number K063136. 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 NEEDLELESS SLING?

NEEDLELESS SLING is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is Specialities Remeex International, S.L.. The 510(k) number is K063136.

When did NEEDLELESS SLING receive FDA 510(k) clearance?

NEEDLELESS SLING received FDA 510(k) clearance on 2006-12-19, under 510(k) number K063136.

Who is the listed applicant for NEEDLELESS SLING?

The FDA 510(k) record lists Specialities Remeex International, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLELESS SLING?

The FDA product code for NEEDLELESS SLING 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

Other records listing Specialities Remeex International, S.L. 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.

K062341MALE REMEEX SYSTEMK033310REMEEX SYSTEM FOR URINARY INCONTINENCE

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.

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