SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K122299
Device Name SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
Applicant
TRANSENTERIX, INC.
635 davis drive suite 300
durham, 
NC 
27713

Applicant Contact tammy b carrea
Correspondent
TRANSENTERIX, INC.
635 davis drive suite 300
durham, 
NC 
27713

Correspodent Contact tammy b carrea
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 07/31/2012
Decision Date 10/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No