510(k) K940049

KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS by Baxter Healthcare Corp — Product Code HET

K940049 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on May 6, 1994. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1994
Date Received
Jan 5, 1994
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
510(k)

Source: FDA 510(k) database entry for K940049. Report a data issue: hello@regdatalab.com.