Blade, Handle, Scalpel Forceps, Surgery

FDA 510(k) K810572 · Technical Resources, Inc.

Substantially Equivalent

510(k) numberK810572

Submission

Device name
Blade, Handle, Scalpel Forceps, Surgery
Applicant
Technical Resources, Inc.
Mchenry, IL, US
Received
March 3, 1981
Decision date
March 20, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GES – Blade, Scalpel
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GES

510(k)DeviceApplicantDecision
K032242Personna Plus Safety Scalpel SystemGES · Traditional Omi Manufacturing Pty., Ltd.09/23/2003SE
K932998Easy-OnGES · Traditional Devon Industries, Inc.08/18/1993SE
K923170Los Alamos Retractable KnifeGES · Traditional Innovative Surgical Technology, Inc.02/18/1993SE
K915119Scalpel Blade Remover (Bladegard)GES · Traditional Intergrated Visual, Inc.05/05/1992SE
K911913Precision Glide - Enhanced Surgical BladeGES · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic05/13/1991SE
K900266Sterile Carbon Steel Surgical BladeGES · Traditional Rahn Laboratories03/01/1990SE
K884862Anchor Double-Edge Myringotomy BladeGES · Traditional Anchor Products Co.12/27/1988SE
K881638Surgical BladeGES · Traditional Far East Intl. Trading Corp.06/15/1988SE
K880244Surgical BladesGES · Traditional Ailee C/O Havel'S, Inc.02/10/1988SE
K873493Ninja ScalpelGES · Traditional Primrose Medical, Inc.09/24/1987SE

More from Primrose Medical, Inc.

510(k)DeviceDecision
K792473Therapette, Model No MH-100GZJ · Traditional 12/20/1979SE
K790805Drug Abuse DipsticksDIT · Traditional 06/06/1979SE

Questions and answers

When was Blade, Handle, Scalpel Forceps, Surgery cleared by the FDA?

Blade, Handle, Scalpel Forceps, Surgery (K810572) received a 510(k) decision of Substantially Equivalent on March 20, 1981, 17 days after the submission was received.

What is the product code of K810572?

The FDA product code is GES – Blade, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.