The Eleventh Finger

FDA 510(k) K923835 · Guardian Angel Products, Inc.

Substantially Equivalent

510(k) numberK923835

Submission

Device name
The Eleventh Finger
Applicant
Guardian Angel Products, Inc.
Washington, DC, US
Received
July 31, 1992
Decision date
July 9, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GDF – Guide, Needle, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GDF

510(k)DeviceApplicantDecision
K031173Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013GDF · Traditional Needle Tech Products, Inc.07/23/2003SE
K950311Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional Global Medical Products, Ltd.05/26/1995SE
K950007Surgical Instrument GuideGDF · Traditional United States Surgical, A Division of Tyco Healthc03/15/1995SE
K945124Breast Lesion Localization NeedleGDF · Traditional Promex, Inc.11/22/1994SE
K944942Breast Lesion Localization NeedleGDF · Traditional Promedical , Ltd.11/04/1994SE
K935538Bauer Temno Coaxial NeedleGDF · Traditional Bauer Medical, Inc.02/22/1994SE
K935457Localization Wire or Marker - SurgicalGDF · Traditional Bip USA, Inc.02/17/1994SE
K923840Needle-GrabberGDF · Traditional Guardian Angel Products, Inc.07/13/1993SE
K925875Horizontal Needle Guide AttachmentGDF · Traditional Bip USA, Inc.04/06/1993SE
K924270Breast Lesion Localization NeedleGDF · Traditional Core Medical, Inc.09/23/1992SE

More from Core Medical, Inc.

510(k)DeviceDecision
K030547Modification to Zap Guard Defibrillator Test ProbeDRL · Special 07/11/2003SE
K923840Needle-GrabberGDF · Traditional 07/13/1993SE
K910687Guardian Gel, Surgeon's Gloving CreamKGQ · Traditional 10/11/1991SE
K896985Zap-GuardDRL · Traditional 07/31/1990SE

Questions and answers

When was The Eleventh Finger cleared by the FDA?

The Eleventh Finger (K923835) received a 510(k) decision of Substantially Equivalent on July 9, 1993, 343 days after the submission was received.

What is the product code of K923835?

The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.