Cleared Traditional

K021676 - CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (FDA 510(k) Clearance)

K021676 · Cypress Medical Products, Ltd. · Obstetrics & Gynecology device

Jul 2002

Decision

52d

Days

Class 2

Risk

K021676 is an FDA 510(k) clearance for the CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on July 12, 2002, 52 days after receiving the submission on May 21, 2002.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K021676 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 21, 2002
Decision Date	July 12, 2002
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement