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GDT — Staple, Removable (Skin) Class I

FDA Device Classification

Classification Details

Product Code
GDT
Device Class
Class I
Regulation Number
878.4760
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K963234continental medical laboratoriesSTAPLE REMOVAL KITOctober 21, 1996
K943719pilling weckVISISTAT STAPLERAugust 24, 1994
K925526matsutani seisakusho co.MANIPLER DISPOSABLE SKIN STAPLERJune 24, 1993
K915430cypress medical productsSKIN STAPLE REMOVER KITFebruary 28, 1992
K911204deroyal industriesQUALTEX SKIN STAPLE EXTRACTORMay 8, 1991
K910586united states surgical, a division of tyco healthcAUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*March 7, 1991
K900486davis and geckAPPOSE UNITY STERILE DISPOSABLE SKIN STAPLERApril 20, 1990
K861711busse hospital disposablesSKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLEMay 16, 1986
K851974american v. muellerV. MUELLER VITAL SKIN STAPLERJune 11, 1985
K844838edward weckSKIN STAT II SKIN STAPLING MEDICAL DEVICEJanuary 23, 1985
K844837edward weckVISISTAT SKIN STAPLING DEVICEJanuary 23, 1985
K833085prosperSTAPLE REMOVER SR300PDecember 14, 1984
K833357ethiconVYDAX 525-550 & 5100 FLUOROTELOMERDecember 12, 1983
K832709prosperSKIN STAPLING DEVICE SC2000September 26, 1983
K822365tri-stateCENTURION SKIN STAPLE REMOVERAugust 27, 1982
K821024howmedicaDISP. SKIN STAPLER REMOVALBLE SKINSTAPLEMay 14, 1982
K801444edward weckSKIN STAPLE REMOVER #523770July 14, 1980
K8005353m3M DISPOSABLE SKIN STAPLERApril 4, 1980
K760734ethiconREGULAR AND WIDE SKIN STAPLESNovember 3, 1976