510(k) K931561

TROCAR SLEEVE by L.A.S.E.R., Inc. — Product Code HET

K931561 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "TROCAR SLEEVE". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
March 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type