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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 the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) 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. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K191416.

When did Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack receive FDA 510(k) clearance?

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 510(k) number K191416.

Who is the listed applicant for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

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

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.

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.

NCT04772131Desara ® One Single Incision Sling 522 StudyACTIVE_NOT_RECRUITING

Other records listing Caldera Medical, 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.

K233500Benesta Tissue Removal DeviceK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemK192811BenestaTM Tissue Removal DeviceK192822Benesta HysteroscopeK193603Benesta Medical Sterilization TrayK172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left

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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/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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