HCFClass I

Instrument, Ligature Passing And Knot Tying

21 CFR 878.4800 / General, Plastic Surgery

HCF is the FDA product code for Instrument, Ligature Passing And Knot Tying, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2015-06-16, and 5 recalls.

Classification record

Product code: HCF
Device name: Instrument, Ligature Passing And Knot Tying
Regulation: 21 CFR 878.4800
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 5

Clearances, product code HCF

By decision year

5 clearances under product code HCF with a decision year between 1979 and 2015, 1979 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HCF by decision year
Year	Clearances
1979	1
1984	1
1985	1
1993	1
2015	1

Applicants with the most clearances

Product code HCF

Applicants holding the most 510(k) clearances under product code HCF
Applicant	Clearances
Boston Scientific Corporation	1
Davis & Geck, Inc.	1
Edwards Lifesciences LLC	1
J. Sklar Mfg. Co., Inc.	1
Plastafil, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 154 companies shown, in name order