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)

CONDOMS (MULTIPLE BRANDS)

K-Number: K897129 · 1990-05-16

ApplicantSagami, Inc.
Decision Date1990-05-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONDOMS (MULTIPLE BRANDS) is the device name listed in this FDA 510(k) record. The listed applicant is Sagami, Inc.. It received FDA 510(k) clearance on 1990-05-16 under 510(k) number K897129. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDOMS (MULTIPLE BRANDS)?

CONDOMS (MULTIPLE BRANDS) is a medical device that received FDA 510(k) clearance on 1990-05-16. The listed applicant is Sagami, Inc.. The 510(k) number is K897129.

When did CONDOMS (MULTIPLE BRANDS) receive FDA 510(k) clearance?

CONDOMS (MULTIPLE BRANDS) received FDA 510(k) clearance on 1990-05-16, under 510(k) number K897129.

Who is the listed applicant for CONDOMS (MULTIPLE BRANDS)?

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

What is the FDA product code for CONDOMS (MULTIPLE BRANDS)?

The FDA product code for CONDOMS (MULTIPLE BRANDS) is HIS.

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

Related Devices (Code: HIS)

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., 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.

↑