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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 the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2023-02-15 under 510(k) 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. The listed applicant is Coloplast A/S. The 510(k) number is K221874.

When did Altis Single Incision Sling System receive FDA 510(k) clearance?

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

Who is the listed applicant for Altis Single Incision Sling System?

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

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

The FDA product code for Altis Single Incision 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.

NCT04115605A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary IncontinenceTERMINATEDNCT05619003Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at RiskCOMPLETEDNCT06985888New Coating for Urinary Intermittent CathetersCOMPLETED

Other records listing Coloplast A/S 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.

K262045Luja SoftK220420Saffron Fixation SystemK191536Biatain Silicone AgK181811ReTrace Ureteral Access SheathK173527Digitex Delivery Device

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.K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc.

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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