510(k) K932295

NON-BALLOON REPLACEMENT GASTROSTOMY KIT by Biosearch Medical Products, Inc. — Product Code KNT

K932295 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "NON-BALLOON REPLACEMENT GASTROSTOMY KIT". The FDA issued a decision of Substantially Equivalent on September 8, 1994. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
May 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type