Cleared Traditional

K884057 - ELAN-E DISPOSABLE DRAPE
(FDA 510(k) Clearance)

K884057 · Aesculap Instruments Corp. · General Hospital

Oct 1988

Decision

23d

Days

Class 2

Risk

K884057 is an FDA 510(k) clearance for the ELAN-E DISPOSABLE DRAPE. This device is classified as a Drape, Surgical (Class II — Special Controls, product code KKX).

Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on October 19, 1988, 23 days after receiving the submission on September 26, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K884057 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 1988
Decision Date	October 19, 1988
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—