510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895516Substantially Equivalent

Cavity Drainage Catheterization Set, Cs-01600

Arrow Intl., Inc., Reading PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895516 is the FDA 510(k) clearance record for CAVITY DRAINAGE CATHETERIZATION SET, CS-01600, a class I device, cleared for Arrow Intl., Inc. on under FDA product code GBX (Catheter, Irrigation). FDA records list 111 510(k) clearances for Arrow Intl., Inc., from to . As of , FDA records show no recalls naming K895516.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Arrow Intl., Inc. P.O. Box 6306, Reading PA
Third party review
No

Clearances, product code GBX

Trailing 12 months

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

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