510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983187Substantially Equivalent

Medsol Goldenberg Bone Marrow Biopsy Needle

Medsol Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983187 is the FDA 510(k) clearance record for MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE, a class II device, cleared for Medsol Corp. on under FDA product code KNW (Instrument, Biopsy). FDA records list one 510(k) clearance for Medsol Corp. As of , FDA records show no recalls naming K983187.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medsol Corp. 4 Washington Sq. Village 8p, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260