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FDA 510(k)

Altis Single Incision Sling System

K-Number: K221874 · 2023-02-15

ApplicantColoplast A/S
Decision Date2023-02-15
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Altis Single Incision Sling System is a medical device manufactured by Coloplast A/S. It received FDA 510(k) clearance on 2023-02-15 under approval number K221874. 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?

Altis Single Incision Sling System is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by Coloplast A/S. The 510(k) number is K221874.

When was Altis Single Incision Sling System approved by the FDA?

Altis Single Incision Sling System received FDA 510(k) clearance on 2023-02-15, under approval number K221874.

What company makes Altis Single Incision Sling System?

Altis Single Incision Sling System is manufactured by Coloplast A/S.

What is the FDA product code for Altis Single Incision Sling System?

The FDA product code for Altis Single Incision Sling System is PAH.

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Other Devices by Coloplast A/S

K181811ReTrace Ureteral Access Sheath K173527Digitex Delivery Device K191536Biatain Silicone Ag K220420Saffron Fixation System

Related Devices (Code: PAH)

K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp.

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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