510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203633Substantially Equivalent

Enteral Extension Sets

Gbuk Group Limited, Selby, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K203633 is the FDA 510(k) clearance record for Enteral Extension Sets, a class II device, cleared for GBUK Group, Ltd. on under FDA product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors). FDA's definition for product code PIF reads: "To facilitate enteral specific connections". FDA records list 2 510(k) clearances for GBUK Group, Ltd., from to . As of , FDA records show no recalls naming K203633.

Clearance record

Decision date
Received
(251 days to decision)
Product code
PIF Gastrointestinal Tubes With Enteral Specific Connectors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
GBUK Group, Ltd. Blackwood Hall Business Park, N. Duffield, Selby, GB
510(k) summary
Statement
Third party review
No

Clearances, product code PIF

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