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Pro Fit Disposable Rectal Speculum, Models 8116 and 8117

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050112

by Prime Pacific Health Innovations Corporation

Identifiers

510(k) Number
K050112 FDA 510(k)
FDA Product Code
KPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5220 FDA 510(k)
Regulation Number
876.5220 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pro Fit Disposable Rectal Speculum is a medical device used for examination procedures of the rectum. It is available in two models, 8116 and 8117, and is designed for single-use to ensure hygiene and prevent cross-contamination.

This disposable speculum is supplied sterile and is intended for single-use only. It is classified under product code KPL and has received FDA 510(k) clearance as substantially equivalent, with authorization number K050112. The device is regulated for use in gastroenterology and urology procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Prime Pacific Health Innovations Corporation

Sources (1)

  • FDA 510(k) K050112 24 fields · synced Oct 6, 2026