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FDA 510(k)

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

K-Number: K050112 · 2005-03-15

ApplicantPrime Pacific Health Innovations Corporation
Decision Date2005-03-15
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 is the device name listed in this FDA 510(k) record. The listed applicant is Prime Pacific Health Innovations Corporation. It received FDA 510(k) clearance on 2005-03-15 under 510(k) number K050112. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117?

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 is a medical device that received FDA 510(k) clearance on 2005-03-15. The listed applicant is Prime Pacific Health Innovations Corporation. The 510(k) number is K050112.

When did PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 receive FDA 510(k) clearance?

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 received FDA 510(k) clearance on 2005-03-15, under 510(k) number K050112.

Who is the listed applicant for PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117?

The FDA 510(k) record lists Prime Pacific Health Innovations Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117?

The FDA product code for PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 is KPL.

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 Prime Pacific Health Innovations Corporation 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.

K000031AQUANET, MODEL EC 2000

Related Devices (Code: KPL)

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.

K201861Bio Fluff SystemGnali Bocia S.R.L.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, 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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