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)

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

K-Number: K252939 · 2025-10-09

Decision Date2025-10-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Cotton High Tech S.L.. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K252939. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K252939.

When did COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS receive FDA 510(k) clearance?

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252939.

Who is the listed applicant for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

The FDA 510(k) record lists Cotton High Tech S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

The FDA product code for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS is HEB.

Other records listing Cotton High Tech S.L. 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.

Related Devices (Code: HEB)

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.

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.