510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982646Substantially Equivalent

Ailee Sutures and Ailee Needles

Myco Medical Supplies Inc, Cary NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982646 is the FDA 510(k) clearance record for AILEE SUTURES AND AILEE NEEDLES, a class II device, cleared for Myco Medical Supplies, Inc. on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list 12 510(k) clearances for Myco Medical Supplies, Inc., from to . As of , FDA records show no recalls naming K982646.

Clearance record

Decision date
Received
(308 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Myco Medical Supplies, Inc. 101 Rose Valley Woods Dr., Cary NC
510(k) summary
Statement
Third party review
No

Clearances, product code GAL

Trailing 12 months

FDA records hold no clearances under product code GAL in the trailing twelve months.

FDA records show no clearances under product code GAL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260