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FDA 510(k)

DESARA MINI

K-Number: K103418 · 2011-11-30

ApplicantCaldera Medical, Inc.
Decision Date2011-11-30
Product CodePAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DESARA MINI 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 2011-11-30 under 510(k) number K103418. 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 MINI?

DESARA MINI is a medical device that received FDA 510(k) clearance on 2011-11-30. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K103418.

When did DESARA MINI receive FDA 510(k) clearance?

DESARA MINI received FDA 510(k) clearance on 2011-11-30, under 510(k) number K103418.

Who is the listed applicant for DESARA MINI?

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 MINI?

The FDA product code for DESARA MINI is PAH.

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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 TrayK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

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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/SK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc.K121562ALTIS SINGLE INCISION CLING SYSTEMColoplast A/SK123179AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLINGC.R. Bard, Inc.K121641MINIARC PRO SINGLE-INCISION SLING SYSTEMAmerican Medical Systems

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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