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FDA 510(k)

GELSKIN

K-Number: K791162 · 1979-09-04

ApplicantSpenco Medical Corp.
Decision Date1979-09-04
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GELSKIN is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791162. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELSKIN?

GELSKIN is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Spenco Medical Corp.. The 510(k) number is K791162.

When did GELSKIN receive FDA 510(k) clearance?

GELSKIN received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791162.

Who is the listed applicant for GELSKIN?

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

What is the FDA product code for GELSKIN?

The FDA product code for GELSKIN is ILO.

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Other records listing Spenco Medical 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.

K981902SPENCO SILICONE GEL SHEETK9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK896533SPENCO BREAST FORMSK8948982ND SKIN NON-STICK MOIST BURN PADS

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Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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