Cleared Traditional

K874243 - ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 (FDA 510(k) Clearance)

K874243 · Pilling Co. · General & Plastic Surgery device

Nov 1987

Decision

28d

Days

Class 1

Risk

K874243 is an FDA 510(k) clearance for the ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on November 13, 1987, 28 days after receiving the submission on October 16, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K874243 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 16, 1987
Decision Date	November 13, 1987
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—