510(k) K912129

DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE by Biosearch Medical Products, Inc. — Product Code KNS

K912129 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type