Cleared Traditional

K885274 - ROCKET ENDOCERVICAL BRUSH
(FDA 510(k) Clearance)

K885274 · A & A Medical, Inc. · Obstetrics & Gynecology

Mar 1989

Decision

77d

Days

Class 2

Risk

K885274 is an FDA 510(k) clearance for the ROCKET ENDOCERVICAL BRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on March 9, 1989, 77 days after receiving the submission on December 22, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K885274 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1988
Decision Date	March 09, 1989
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—