Los Alamos Retractable Knife

FDA 510(k) K923170 · Innovative Surgical Technology, Inc.

Substantially Equivalent

510(k) numberK923170

Submission

Device name
Los Alamos Retractable Knife
Applicant
Innovative Surgical Technology, Inc.
Los Alamos, NM, US
Received
June 29, 1992
Decision date
February 18, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K873142Personna Disposable ScalpelGES · Traditional American Safety Razor Co.09/04/1987SE

Questions and answers

When was Los Alamos Retractable Knife cleared by the FDA?

Los Alamos Retractable Knife (K923170) received a 510(k) decision of Substantially Equivalent on February 18, 1993, 234 days after the submission was received.

What is the product code of K923170?

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