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)

Puritan Fecal Opti-Swab Collection and Transport System

K-Number: K162284 · 2016-11-04

ApplicantPuritan Medical Products, LLC
Decision Date2016-11-04
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Puritan Fecal Opti-Swab Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162284. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Puritan Fecal Opti-Swab Collection and Transport System?

Puritan Fecal Opti-Swab Collection and Transport System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Puritan Medical Products, LLC. The 510(k) number is K162284.

When did Puritan Fecal Opti-Swab Collection and Transport System receive FDA 510(k) clearance?

Puritan Fecal Opti-Swab Collection and Transport System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162284.

Who is the listed applicant for Puritan Fecal Opti-Swab Collection and Transport System?

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

What is the FDA product code for Puritan Fecal Opti-Swab Collection and Transport System?

The FDA product code for Puritan Fecal Opti-Swab Collection and Transport System is JSM.

Other records listing Puritan Medical Products, LLC 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.

K242820Puritan PurSafe Plus Collection and Transport SystemK160082Puritan Opti-Tranz Cary-Blair Collection and Transport System

Related Devices (Code: JSM)

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.

K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.

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.

↑