FKCClass I

Clamp, Cannula

21 CFR 876.5540 / Gastroenterology, Urology

FKC is the FDA product code for Clamp, Cannula, a class I device type, regulated under 21 CFR 876.5540. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1977-08-26, and no recalls.

Classification record

Product code: FKC
Device name: Clamp, Cannula
Regulation: 21 CFR 876.5540
Device class: Class I
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code FKC

By decision year

1 clearance under product code FKC with a decision year between 1977 and 1977, 1977 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code FKC by decision year
Year	Clearances
1977	1

Applicants with the most clearances

Product code FKC

Applicants holding the most 510(k) clearances under product code FKC
Applicant	Clearances
Quinton, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order

Recent clearances

Product code FKC

K771419Class ICannula ClampQuinton, Inc. / cleared 1977-08-26

Recent recalls

Product code FKC

FDA records show no recalls under product code FKC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)