510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961693Substantially Equivalent

Dale Gastrostomy Tube Holder

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

K961693 is the FDA 510(k) clearance record for DALE GASTROSTOMY TUBE HOLDER, a class II device, cleared for Dale Medical Products, Inc. on under FDA product code PLI (Gastrointestional Tube Holder). FDA's definition for product code PLI reads: "Intended to support, secure, and hold gastrointestinal tubes". FDA records list 13 510(k) clearances for Dale Medical Products, Inc., from to . As of , FDA records show no recalls naming K961693.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PLI Gastrointestional Tube Holder
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dale Medical Products, Inc. 7 Cross St., Plainville MA
510(k) summary
Statement
Third party review
No

Clearances, product code PLI

Trailing 12 months

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

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