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)

NESSI OTC SPACER

K-Number: K101532 · 2010-09-01

ApplicantPharmacaribe
Decision Date2010-09-01
Product CodeNVO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NESSI OTC SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacaribe. It received FDA 510(k) clearance on 2010-09-01 under 510(k) number K101532. The device is classified under product code NVO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NESSI OTC SPACER?

NESSI OTC SPACER is a medical device that received FDA 510(k) clearance on 2010-09-01. The listed applicant is Pharmacaribe. The 510(k) number is K101532.

When did NESSI OTC SPACER receive FDA 510(k) clearance?

NESSI OTC SPACER received FDA 510(k) clearance on 2010-09-01, under 510(k) number K101532.

Who is the listed applicant for NESSI OTC SPACER?

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

What is the FDA product code for NESSI OTC SPACER?

The FDA product code for NESSI OTC SPACER is NVO.

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 Pharmacaribe 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.

K130091PULMOSALK101424PHARMACARIBE INHALED SALINE SOLUTIONSK091862NESSI SPACER

Related Devices (Code: NVO)

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.

K091862NESSI SPACERPharmacaribe

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.

↑