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FDA 510(k)

CRYOSIL SILICONE GEL SHEETING

K-Number: K964047 · 1997-03-19

ApplicantBiodermis Corp.
Decision Date1997-03-19
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOSIL SILICONE GEL SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Biodermis Corp.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K964047. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOSIL SILICONE GEL SHEETING?

CRYOSIL SILICONE GEL SHEETING is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Biodermis Corp.. The 510(k) number is K964047.

When did CRYOSIL SILICONE GEL SHEETING receive FDA 510(k) clearance?

CRYOSIL SILICONE GEL SHEETING received FDA 510(k) clearance on 1997-03-19, under 510(k) number K964047.

Who is the listed applicant for CRYOSIL SILICONE GEL SHEETING?

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

What is the FDA product code for CRYOSIL SILICONE GEL SHEETING?

The FDA product code for CRYOSIL SILICONE GEL SHEETING is GEH.

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.

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Other records listing Biodermis Corp. 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.

K003948EPI-DERM SILICONE GEL SHEETINGK992146SCARAID SILICONE GEL SHEETINGK991604EPI-FOAM SILICONE SHEETINGK942156EPI-DERM SILICONE GEL SHEETING

Related Devices (Code: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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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