510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980002Substantially Equivalent

Koala Vascular Clamps and Inserts

Boss Instruments, Ltd., Hermitage TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980002 is the FDA 510(k) clearance record for KOALA VASCULAR CLAMPS AND INSERTS, a class II device, cleared for Boss Instruments, Ltd. on under FDA product code DXC (Clamp, Vascular). FDA records list one 510(k) clearance for Boss Instruments, Ltd. As of , FDA records show no recalls naming K980002.

Clearance record

Decision date
Received
(167 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Boss Instruments, Ltd. 1310 Central Ct., Hermitage TN
510(k) summary
Summary
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260