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FDA 510(k)

MALIS BIPOLAR PEN

K-Number: K853168 · 1985-08-12

ApplicantValley Forge Scientific Corp.
Decision Date1985-08-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MALIS BIPOLAR PEN is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K853168. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALIS BIPOLAR PEN?

MALIS BIPOLAR PEN is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K853168.

When did MALIS BIPOLAR PEN receive FDA 510(k) clearance?

MALIS BIPOLAR PEN received FDA 510(k) clearance on 1985-08-12, under 510(k) number K853168.

Who is the listed applicant for MALIS BIPOLAR PEN?

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

What is the FDA product code for MALIS BIPOLAR PEN?

The FDA product code for MALIS BIPOLAR PEN is GEI.

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Other records listing Valley Forge Scientific 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.

K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMK042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSK032601STRYKER INTERVENTIONAL PAIN RF GENERATORK033499MALIS IRRIGATION MODULE 1000K982229BI-DENTK973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

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Related Devices (Code: GEI)

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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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