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FDA 510(k)

CHOICE

K-Number: K864482 · 1986-12-22

ApplicantSelect Sources, Inc.
Decision Date1986-12-22
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CHOICE is the device name listed in this FDA 510(k) record. The listed applicant is Select Sources, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K864482. 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 CHOICE?

CHOICE is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Select Sources, Inc.. The 510(k) number is K864482.

When did CHOICE receive FDA 510(k) clearance?

CHOICE received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864482.

Who is the listed applicant for CHOICE?

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

What is the FDA product code for CHOICE?

The FDA product code for CHOICE is HIS.

Related Clinical Trials

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Related PubMed Literature

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.

PMID: 41483527Systematic review of usability evaluations in medical devices: Methodological choices, heuristic application, and confounding factors.Applied ergonomics ()

Other records listing Select Sources, 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.

K884328CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)K883705FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMASK883033PISTON SYRINGE WITH NEEDLEK883078INSULIN SYRINGEK880919(CHOICE) ALSO (KONDUM)K863190CHOICE CONDOM

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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.

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