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FDA 510(k)

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

K-Number: K191416 · 2020-02-07

ApplicantCaldera Medical, Inc.
Decision Date2020-02-07
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-02-07 under approval number K191416. 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 Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is a medical device that received FDA 510(k) clearance on 2020-02-07. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K191416.

When was Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack approved by the FDA?

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack received FDA 510(k) clearance on 2020-02-07, under approval number K191416.

What company makes Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is manufactured by Caldera Medical, Inc..

What is the FDA product code for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

The FDA product code for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is PAH.

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Other Devices by Caldera Medical, Inc.

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Related Devices (Code: PAH)

K221874Altis Single Incision Sling SystemColoplast A/S 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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