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FDA 510(k)

SAVI PREPARATION DEVICE

K-Number: K101411 · 2010-07-12

ApplicantCianna Medical, Inc.
Decision Date2010-07-12
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAVI PREPARATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cianna Medical, Inc.. It received FDA 510(k) clearance on 2010-07-12 under 510(k) number K101411. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVI PREPARATION DEVICE?

SAVI PREPARATION DEVICE is a medical device that received FDA 510(k) clearance on 2010-07-12. The listed applicant is Cianna Medical, Inc.. The 510(k) number is K101411.

When did SAVI PREPARATION DEVICE receive FDA 510(k) clearance?

SAVI PREPARATION DEVICE received FDA 510(k) clearance on 2010-07-12, under 510(k) number K101411.

Who is the listed applicant for SAVI PREPARATION DEVICE?

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

What is the FDA product code for SAVI PREPARATION DEVICE?

The FDA product code for SAVI PREPARATION DEVICE is JAQ.

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Other records listing Cianna 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.

K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK161507Cianna Medical SAVI Scout Reflector and SAVI Scout SystemK132463CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEMK081677SAVI APPLICATOR KITK080565MODIFICATION TO: SAVI APPLICATOR KIT

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Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian 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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