510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863034Substantially Equivalent

Sharpoint Stainless Steel Suture

Chathamborough Research Group, Inc., Pittsboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863034 is the FDA 510(k) clearance record for SHARPOINT STAINLESS STEEL SUTURE, a class II device, cleared for Chathamborough Research Group, Inc. on under FDA product code GAO (Suture, Nonabsorbable). FDA records list 4 510(k) clearances for Chathamborough Research Group, Inc., from to . As of , FDA records show no recalls naming K863034.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GAO Suture, Nonabsorbable
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Chathamborough Research Group, Inc. 105 W. St., Pittsboro NC
Third party review
No

Clearances, product code GAO

Trailing 12 months

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

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