PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE


Device Classification Name

endoscope and/or accessories

510(k) Number K073671
Device Name PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
Applicant
NDO SURGICAL, INC.
125 high st.,
suite 7
mansfield, 
MA 
02048

Applicant Contact john j vozella
Correspondent
NDO SURGICAL, INC.
125 high st.,
suite 7
mansfield, 
MA 
02048

Correspodent Contact john j vozella
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 12/27/2007
Decision Date 03/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No