510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862412Substantially Equivalent

Intestoplant

Burron Medical Products, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862412 is the FDA 510(k) clearance record for INTESTOPLANT, a class II device, cleared for Burron Medical Products, Inc. on under FDA product code LLD (Port & Catheter, Implanted, Subcutaneous, Intraperitoneal). FDA records list 41 510(k) clearances for Burron Medical Products, Inc., from to . As of , FDA records show no recalls naming K862412.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Burron Medical Products, Inc. 824 Twelfth Ave., Bethlehem PA
Third party review
No

Clearances, product code LLD

Trailing 12 months

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

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