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FDA 510(k)

MONOPOLAR INJECTION NEEDLE ELECTRODE

K-Number: K854793 · 1986-02-18

ApplicantOculinum, Inc.
Decision Date1986-02-18
Product CodeHLW
Advisory CommitteeOP
DecisionSubstantially Equivalent for Some Indications

Device Summary

MONOPOLAR INJECTION NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Oculinum, Inc.. It received FDA 510(k) clearance on 1986-02-18 under 510(k) number K854793. The device is classified under product code HLW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MONOPOLAR INJECTION NEEDLE ELECTRODE?

MONOPOLAR INJECTION NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-02-18. The listed applicant is Oculinum, Inc.. The 510(k) number is K854793.

When did MONOPOLAR INJECTION NEEDLE ELECTRODE receive FDA 510(k) clearance?

MONOPOLAR INJECTION NEEDLE ELECTRODE received FDA 510(k) clearance on 1986-02-18, under 510(k) number K854793.

Who is the listed applicant for MONOPOLAR INJECTION NEEDLE ELECTRODE?

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

What is the FDA product code for MONOPOLAR INJECTION NEEDLE ELECTRODE?

The FDA product code for MONOPOLAR INJECTION NEEDLE ELECTRODE is HLW.

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 Oculinum, 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.

K900098MONOPOLAR NEEDLE ELECTRODEK900279OCULINUM INJECTION AMPLIFIER

Related Devices (Code: HLW)

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.

K900098MONOPOLAR NEEDLE ELECTRODEOculinum, Inc.K900279OCULINUM INJECTION AMPLIFIEROculinum, 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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