Cleared Traditional

K963505 - TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
(FDA 510(k) Clearance)

K963505 · Tenet Medical Engineering · Obstetrics & Gynecology device
Feb 1997
Decision
164d
Days
Class 2
Risk

K963505 is an FDA 510(k) clearance for the TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM. This device is classified as a Table, Obstetrical, Manual (and Accessories) (Class II - Special Controls, product code HHP).

Submitted by Tenet Medical Engineering (Calgary, CA). The FDA issued a Cleared decision on February 14, 1997, 164 days after receiving the submission on September 3, 1996.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.

Submission Details

510(k) Number K963505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date February 14, 1997
Days to Decision 164 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HHP — Table, Obstetrical, Manual (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.4900