510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801261Substantially Equivalent

Disposable Coupling Adaptor

Intec Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801261 is the FDA 510(k) clearance record for DISPOSABLE COUPLING ADAPTOR, a class I device, cleared for Intec Medical, Inc. on under FDA product code BYX (Tubing, Pressure And Accessories). FDA records list 17 510(k) clearances for Intec Medical, Inc., from to . As of , FDA records show no recalls naming K801261.

Clearance record

Decision date
Received
(12 days to decision)
Product code
BYX Tubing, Pressure And Accessories
Regulation
21 CFR 868.5860
Device class
Class I
Review panel
Anesthesiology
Applicant
Intec Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYX

Trailing 12 months

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

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