510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161003Unknown

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

Boston Scientific Corporation, Marlboro MA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161003 is the FDA 510(k) clearance record for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector, a class II device, cleared for Boston Scientific Corporation 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 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K161003.

Clearance record

Decision date
Received
(67 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
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
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