510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882169Substantially Equivalent

Surgical Duct Clamp (Vine)

Henley Intl., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882169 is the FDA 510(k) clearance record for SURGICAL DUCT CLAMP (VINE), a class I device, cleared for Henley Intl. on under FDA product code GDJ (Clamp, Surgical, General & Plastic Surgery). FDA records list 44 510(k) clearances for Henley Intl., from to . As of , FDA records show no recalls naming K882169.

Clearance record

Decision date
Received
(24 days to decision)
Product code
GDJ Clamp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Henley Intl. 104 Industrial Blvd.,, Sugar Land TX
Third party review
No

Clearances, product code GDJ

Trailing 12 months

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

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