510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033562Substantially Equivalent

Fastrac Gastric Access Port Kit

C.R. Bard Inc, Billerica MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033562 is the FDA 510(k) clearance record for FASTRAC GASTRIC ACCESS PORT KIT, a class II device, cleared for C.R. Bard, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show 29 recalls naming K033562.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 129 Concord Rd., Billerica MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260