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FDA 510(k)

AMS SINGLE INCISION SLING SYSTEM (SIS-0)

K-Number: K070065 · 2007-03-01

ApplicantAmerican Medical Systems, Inc.
Decision Date2007-03-01
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMS SINGLE INCISION SLING SYSTEM (SIS-0) is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K070065. 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 AMS SINGLE INCISION SLING SYSTEM (SIS-0)?

AMS SINGLE INCISION SLING SYSTEM (SIS-0) is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K070065.

When did AMS SINGLE INCISION SLING SYSTEM (SIS-0) receive FDA 510(k) clearance?

AMS SINGLE INCISION SLING SYSTEM (SIS-0) received FDA 510(k) clearance on 2007-03-01, under 510(k) number K070065.

Who is the listed applicant for AMS SINGLE INCISION SLING SYSTEM (SIS-0)?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMS SINGLE INCISION SLING SYSTEM (SIS-0)?

The FDA product code for AMS SINGLE INCISION SLING SYSTEM (SIS-0) 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 American Medical Systems, 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.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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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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