510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864897Substantially Equivalent

Dale Venipuncture Tourniquet, Product No. 1335

Dale Medical Products, Inc., Plainville MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864897 is the FDA 510(k) clearance record for DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335, a class I device, cleared for Dale Medical Products, Inc. on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list 13 510(k) clearances for Dale Medical Products, Inc., from to . As of , FDA records show no recalls naming K864897.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dale Medical Products, Inc. 7 Cross St., Plainville MA
Third party review
No

Clearances, product code GAX

Trailing 12 months

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

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