Instrument, Ligature Passing And Knot Tying
The Ligature Passing and Knot Tying Instrument is a surgical tool used in general and plastic surgery to pass suture material around structures and to tie secure knots in confined or deep anatomical spaces where direct manual tying is difficult. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HCF under regulation 21 CFR 878.4800 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
Basic Information
- Product Code
- HCF
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Jun 16, 2015 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | Jul 13, 1993 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K851452 | VALTRAC PURSESTING DEVICE | Jun 12, 1985 | Substantially Equivalent | DAVIS & GECK, INC. |
| K841617 | STROVER HOOK | Aug 27, 1984 | Substantially Equivalent | PLASTAFIL, INC. |
| K790577 | HEMORRHOIDAL LIGATOR | Apr 23, 1979 | Substantially Equivalent | J. SKLAR MFG. CO., INC. |
FEI Numbers
This FDA classification entry is associated with 162 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 162 registration numbers. Click on an entry to view related FDA registrations.