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FDA 510(k)

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

K-Number: K992438 · 1999-08-02

ApplicantIndus Medicare , Ltd.
Decision Date1999-08-02
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) is the device name listed in this FDA 510(k) record. The listed applicant is Indus Medicare , Ltd.. It received FDA 510(k) clearance on 1999-08-02 under 510(k) number K992438. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)?

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) is a medical device that received FDA 510(k) clearance on 1999-08-02. The listed applicant is Indus Medicare , Ltd.. The 510(k) number is K992438.

When did INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) receive FDA 510(k) clearance?

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) received FDA 510(k) clearance on 1999-08-02, under 510(k) number K992438.

Who is the listed applicant for INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)?

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

What is the FDA product code for INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)?

The FDA product code for INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) is LTZ.

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Other records listing Indus Medicare , Ltd. 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.

K022614INVIGRAK020223INVIGRAK000039INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVOREDK000040INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVOREDK000038INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVOREDK993693INVIGRA

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Related Devices (Code: LTZ)

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.

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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