510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904263Substantially Equivalent

Dacron R Surgical Sutures

Sharppoint, Inc., Readding PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904263 is the FDA 510(k) clearance record for DACRON R SURGICAL SUTURES, a class II device, cleared for Sharppoint, Inc. on under FDA product code GAS (Suture, Nonabsorbable, Synthetic, Polyester). FDA records list one 510(k) clearance for Sharppoint, Inc. As of , FDA records show no recalls naming K904263.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GAS Suture, Nonabsorbable, Synthetic, Polyester
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sharppoint, Inc. P.O. Box 310, Readding PA
Third party review
No

Clearances, product code GAS

Trailing 12 months

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

FDA records show no clearances under product code GAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAS, 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