Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

K-Number: K122246 · 2012-08-13

ApplicantCelleration, Inc.
Decision Date2012-08-13
Product CodeNRB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 is the device name listed in this FDA 510(k) record. The listed applicant is Celleration, Inc.. It received FDA 510(k) clearance on 2012-08-13 under 510(k) number K122246. The device is classified under product code NRB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12?

MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 is a medical device that received FDA 510(k) clearance on 2012-08-13. The listed applicant is Celleration, Inc.. The 510(k) number is K122246.

When did MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 receive FDA 510(k) clearance?

MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 received FDA 510(k) clearance on 2012-08-13, under 510(k) number K122246.

Who is the listed applicant for MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12?

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

What is the FDA product code for MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12?

The FDA product code for MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 is NRB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Celleration, 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.

K050129CELLERATION MIST THERAPY SYSTEM 5.1

Related Devices (Code: NRB)

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.

K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorAlliqua Biomedical, Inc.K123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.K112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMArobella Medical, LLCK050129CELLERATION MIST THERAPY SYSTEM 5.1Celleration, Inc.

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.

↑