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FDA 510(k)

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)

K-Number: K242473 · 2024-10-18

ApplicantColoplast Corp.
Decision Date2024-10-18
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2024-10-18 under approval number K242473. 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 Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is a medical device that received FDA 510(k) clearance on 2024-10-18. It is manufactured by Coloplast Corp.. The 510(k) number is K242473.

When was Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) approved by the FDA?

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) received FDA 510(k) clearance on 2024-10-18, under approval number K242473.

What company makes Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is manufactured by Coloplast Corp..

What is the FDA product code for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

The FDA product code for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is PAH.

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Related Devices (Code: PAH)

K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. K221874Altis Single Incision Sling SystemColoplast A/S

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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