Cleared Traditional

K992178 - BALLOON FOR ULTRASONIC ENDOSCOPES
(FDA 510(k) Clearance)

K992178 · N.M. Beale Co., Inc. · Radiology

May 2000

Decision

319d

Days

Class 2

Risk

K992178 is an FDA 510(k) clearance for the BALLOON FOR ULTRASONIC ENDOSCOPES. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX).

Submitted by N.M. Beale Co., Inc. (Harvard, US). The FDA issued a Cleared decision on May 12, 2000, 319 days after receiving the submission on June 28, 1999.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K992178 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1999
Decision Date	May 12, 2000
Days to Decision	319 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement