Cleared Traditional

REID ENDOCERVICAL SPREADER

K891347 · Simpson/Basye, Inc. · Obstetrics & Gynecology
Mar 1989
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K891347 is an FDA 510(k) clearance for the REID ENDOCERVICAL SPREADER, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 29, 1989, 19 days after receiving the submission on March 10, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K891347 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1989
Decision Date March 29, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HDC — Tenaculum, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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