Atlas FDA

SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES

FDA 510(k) clearance K030919 · decided 2003-07-03

Clearance details

K-number
K030919
Device name
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
Applicant
Medisiss
Decision
Substantially Equivalent
Date received
2003-03-24
Decision date
2003-07-03
Days to decision
101 days
Clearance type
Traditional
Product code
NLR
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Sisters, OR, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.