Cleared Traditional

K980717 - UROMED SLING KIT
(FDA 510(k) Clearance)

K980717 · Uromed Corp. · Obstetrics & Gynecology

May 1998

Decision

87d

Days

Class 2

Risk

K980717 is an FDA 510(k) clearance for the UROMED SLING KIT, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on May 22, 1998, 87 days after receiving the submission on February 24, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K980717 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1998
Decision Date	May 22, 1998
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF