Cleared Traditional

NYLON COATED SPECULA

K925501 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Jun 1997
Decision
1687d
Days
Class 2
Risk

About This 510(k) Submission

K925501 is an FDA 510(k) clearance for the NYLON COATED SPECULA, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 13, 1997, 1687 days after receiving the submission on October 30, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K925501 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1992
Decision Date June 13, 1997
Days to Decision 1687 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIB — Speculum, Vaginal, Nonmetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530