MCZ · Suture Removal Kit
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | MCZ |
|---|---|
| Device Name | Suture Removal Kit |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050656 | AMSINO SUTURE REMOVAL KIT | Amsino International, Inc. | May 2, 2005 | SESE |
| K964827 | PROD. NO. 01-132 - SUTURE REMOVAL KIT | Continental Medical Laboratories, Inc. | Feb 14, 1997 | SESE |
| K963714 | GRAND MEDICAL SUTURE REMOVAL KIT | Grand Medical Products | Nov 27, 1996 | SESE |
| K943046 | SKIN STAPLE REMOVAL TRAYS | Sterile Concepts, Inc. | Jul 29, 1994 | SESK |
| K941465 | SUTURE REMOVAL KIT | Clinical Resources, Inc. | Apr 22, 1994 | SESE |
| K931597 | CARAPACE INCISION AND DRAINAGE TRAYS | Carapace, Inc. | Nov 5, 1993 | SEKD |
| K925015 | STERILE SUTURE REMOVAL KIT | Customed, Inc. | Jun 7, 1993 | SESK |
| K924835 | VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560 | American Healthcare Supply Co., Inc. | Mar 23, 1993 | SESK |
| K924834 | PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) | American Healthcare Supply Co., Inc. | Mar 23, 1993 | SEKD |
| K922339 | SUTURE REMOVAL KIT | Transidyne General Corp. | Dec 11, 1992 | SESK |
| K915827 | A.C.S. SUTURE REMOVAL KIT | American Carolina Stamping | Dec 8, 1992 | SESK |
| K920283 | DISPOSABLE SKIN STAPLE REMOVER | Trinity Laboratories, Inc. | May 22, 1992 | SESE |
| K920280 | SUTURE REMOVAL KIT, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | May 11, 1992 | SESK |
| K910361 | SUTURE REMOVAL KIT | Megadyne Medical Products, Inc. | Mar 27, 1991 | SESE |
| K812132 | STERILE SUTURE REMOVAL KIT | E.M. Adams | Dec 1, 1981 | SESE |
Top Applicants
- Trinity Laboratories, Inc. — 2 clearances
- American Healthcare Supply Co., Inc. — 2 clearances
- Transidyne General Corp. — 1 clearance
- Sterile Concepts, Inc. — 1 clearance
- Megadyne Medical Products, Inc. — 1 clearance
