Li Vasectomy

FDA 510(k) K932465 · Femcare , Ltd.

Substantially Equivalent

510(k) numberK932465

Submission

Device name
Li Vasectomy
Applicant
Femcare , Ltd.
Ng7 3en England, GB
Received
May 21, 1993
Decision date
March 2, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 Li Vasectomy cleared by the FDA?

Li Vasectomy (K932465) received a 510(k) decision of Substantially Equivalent on March 2, 1994, 285 days after the submission was received.

What is the product code of K932465?

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.