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FDA 510(k)

SAFE

K-Number: K013773 · 2002-01-24

ApplicantSsn Medical Products Sdn. Bhd.
Decision Date2002-01-24
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAFE is the device name listed in this FDA 510(k) record. The listed applicant is Ssn Medical Products Sdn. Bhd.. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K013773. 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 SAFE?

SAFE is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Ssn Medical Products Sdn. Bhd.. The 510(k) number is K013773.

When did SAFE receive FDA 510(k) clearance?

SAFE received FDA 510(k) clearance on 2002-01-24, under 510(k) number K013773.

Who is the listed applicant for SAFE?

The FDA 510(k) record lists Ssn Medical Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE?

The FDA product code for SAFE is HIS.

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: 42815842Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.Regulatory toxicology and pharmacology : RTP ()PMID: 42749521Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.Clinical therapeutics ()PMID: 42714465Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.Indian dermatology online journal ()PMID: 42566800Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.Journal of neurosurgery. Pediatrics ()

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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