Cleared Traditional

K000027 - INSUFFLATION NEEDLE, MODEL R65-933
(FDA 510(k) Clearance)

K000027 · A & A Medical, Inc. · Obstetrics & Gynecology

Apr 2000

Decision

89d

Days

Class 2

Risk

K000027 is an FDA 510(k) clearance for the INSUFFLATION NEEDLE, MODEL R65-933, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 3, 2000, 89 days after receiving the submission on January 5, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number	K000027 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2000
Decision Date	April 03, 2000
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF