510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023125Substantially Equivalent

Coalescent U-Clip- and Accessories

Coalescent Surgical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023125 is the FDA 510(k) clearance record for COALESCENT U-CLIP- AND ACCESSORIES, a class II device, cleared for Coalescent Surgical on under FDA product code NJU (Suture, Nonabsorbable, Nitinol). FDA's definition for product code NJU reads: "Soft tissue approximation". FDA records list 9 510(k) clearances for Coalescent Surgical, from to . As of , FDA records show no recalls naming K023125.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NJU Suture, Nonabsorbable, Nitinol
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Coalescent Surgical 559 E. Weddell Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJU

Trailing 12 months

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

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