510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041159Substantially Equivalent

Jms Absorbable Anchor and Applicator

Jms, Inc., Jacksonville Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041159 is the FDA 510(k) clearance record for JMS ABSORBABLE ANCHOR AND APPLICATOR, a class II device, cleared for Jms, Inc. on under FDA product code GDW (Staple, Implantable). FDA records list one 510(k) clearance for Jms, Inc. As of , FDA records show no recalls naming K041159.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Jms, Inc. 1221 1st St. S., Jacksonville Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260