HCF · Instrument, Ligature Passing And Knot Tying
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | HCF |
|---|---|
| Device Name | Instrument, Ligature Passing And Knot Tying |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | Jun 16, 2015 | SESE |
| K931379 | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | Boston Scientific Corp | Jul 13, 1993 | SESE |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | Jun 12, 1985 | SESE |
| K841617 | STROVER HOOK | Plastafil, Inc. | Aug 27, 1984 | SESE |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | Apr 23, 1979 | SESE |
Top Applicants
- Boston Scientific Corp — 1 clearance
- Davis & Geck, Inc. — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance
- J. Sklar Mfg. Co., Inc. — 1 clearance
- Plastafil, Inc. — 1 clearance
