Effner Sims Rectal Speculum W/Fiber Optic Illumina

FDA 510(k) K852014 · Effner and Spreine Co.

Substantially Equivalent

510(k) numberK852014

Submission

Device name
Effner Sims Rectal Speculum W/Fiber Optic Illumina
Applicant
Effner and Spreine Co.
Port Washington, NY, US
Received
May 9, 1985
Decision date
August 7, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KOA – Surgical Instruments, G-U, Manual (And Accessories)
Device class
Class I (low risk)
Regulation
21 CFR 876.4730
Specialty
Gastroenterology, Urology

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Questions and answers

When was Effner Sims Rectal Speculum W/Fiber Optic Illumina cleared by the FDA?

Effner Sims Rectal Speculum W/Fiber Optic Illumina (K852014) received a 510(k) decision of Substantially Equivalent on August 7, 1985, 90 days after the submission was received.

What is the product code of K852014?

The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.