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FDA 510(k)

DESARA MESH MODEL: CAL-DS01

K-Number: K101169 · 2010-05-20

ApplicantCaldera Medical, Inc.
Decision Date2010-05-20
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DESARA MESH MODEL: CAL-DS01 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 2010-05-20 under 510(k) number K101169. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DESARA MESH MODEL: CAL-DS01?

DESARA MESH MODEL: CAL-DS01 is a medical device that received FDA 510(k) clearance on 2010-05-20. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K101169.

When did DESARA MESH MODEL: CAL-DS01 receive FDA 510(k) clearance?

DESARA MESH MODEL: CAL-DS01 received FDA 510(k) clearance on 2010-05-20, under 510(k) number K101169.

Who is the listed applicant for DESARA MESH MODEL: CAL-DS01?

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 MESH MODEL: CAL-DS01?

The FDA product code for DESARA MESH MODEL: CAL-DS01 is OTN.

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Related Devices (Code: OTN)

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.

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena Surgical RMUS SystemAthena Surgical, LLC

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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