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510(k) K923170

Device
LOS ALAMOS RETRACTABLE KNIFE
Applicant
INNOVATIVE SURGICAL TECHNOLOGY, INC.
510(k) number
K923170
Product code
GES  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-18
Date received
1992-06-29
Regulation
878.4800
Classification name
Blade, Scalpel
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL JACKSON
Address
901 18th St. P.O. Box 148 Los Alamos NM US 87544 87544

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GES  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.2003-09-23
K932998EASY-ONDevon Industries, Inc.1993-08-18
K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.1992-05-05
K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems Preanalytic1991-05-13
K900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories1990-03-01
K884862ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADEAnchor Products Co.1988-12-27
K881638SURGICAL BLADEFar East Intl. Trading Corp.1988-06-15
K880244SURGICAL BLADESAilee C/O Havel'S, Inc.1988-02-10
K873493NINJA SCALPELPrimrose Medical, Inc.1987-09-24
K873142PERSONNA DISPOSABLE SCALPELAmerican Safety Razor Co.1987-09-04
K863885SABLE BLADESSable Industries1986-10-24
K863867DEXTRA DISPOSABLE BLADESStorz Instrument Co.1986-10-24
K863214KEISEI MICRO-BLADES (STERILE AND NON-STERILE)Keisei Medical Industrial Co., Ltd.1986-09-02
K863211KEISEI SURGICAL BLADES (STERILE & NON-STERILE)Keisei Medical Industrial Co., Ltd.1986-09-02
K855104ANGIOMED SKIN FASCIA KNIFEAngiomed U.S., Inc.1986-01-24

Legacy Summary#

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FDA Review#

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