510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981853Substantially Equivalent

Bone Injection Gun (B.i.g.) Device

Waismed Ltd., Ginot Shomron 44853, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981853 is the FDA 510(k) clearance record for BONE INJECTION GUN (B.I.G.) DEVICE, a class II device, cleared for Waismed, Ltd. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 7 510(k) clearances for Waismed, Ltd., from to . As of , FDA records show no recalls naming K981853.

Clearance record

Decision date
Received
(175 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Waismed, Ltd. P.o.b. 454, Ginot Shomron 44853, IL
510(k) summary
Statement
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260