HCF — Instrument, Ligature Passing And Knot Tying Class I
FDA product code HCF covers "Instrument, Ligature Passing And Knot Tying", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HCF
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150882 | edwards lifesciences | Edwards Suture Fastening System | June 16, 2015 |
| K931379 | boston scientific | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | July 13, 1993 |
| K851452 | davis and geck | VALTRAC PURSESTING DEVICE | June 12, 1985 |
| K841617 | plastafil | STROVER HOOK | August 27, 1984 |
| K790577 | j. sklar mfg. co | HEMORRHOIDAL LIGATOR | April 23, 1979 |