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FDA 510(k)

LATEX ULTRASONIC PROBE COVER

K-Number: K022156 · 2003-09-11

ApplicantPleasure Latex Products Sdn. Bhd.
Decision Date2003-09-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LATEX ULTRASONIC PROBE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Pleasure Latex Products Sdn. Bhd.. It received FDA 510(k) clearance on 2003-09-11 under 510(k) number K022156. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX ULTRASONIC PROBE COVER?

LATEX ULTRASONIC PROBE COVER is a medical device that received FDA 510(k) clearance on 2003-09-11. The listed applicant is Pleasure Latex Products Sdn. Bhd.. The 510(k) number is K022156.

When did LATEX ULTRASONIC PROBE COVER receive FDA 510(k) clearance?

LATEX ULTRASONIC PROBE COVER received FDA 510(k) clearance on 2003-09-11, under 510(k) number K022156.

Who is the listed applicant for LATEX ULTRASONIC PROBE COVER?

The FDA 510(k) record lists Pleasure Latex Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX ULTRASONIC PROBE COVER?

The FDA product code for LATEX ULTRASONIC PROBE COVER is ITX.

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Other records listing Pleasure Latex Products Sdn. Bhd. 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.

K023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOURK021875MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOMK020272MALE LATEX CONDOM WITH RIBBED SURFACEK002571MULITPLE MALE LATX CONDOMK001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMK001221MALE LATEX COMDOM WITH DOTTED SURFACE

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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