FZW · Expander, Surgical, Skin Graft
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FZW |
|---|---|
| Device Name | Expander, Surgical, Skin Graft |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | Lb Medical LLC | May 2, 2008 | SESE |
| K984448 | BIRCOLL BALLOON DISSECTOR | Wells Johnson Co. | Jan 28, 1999 | SESE |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | General Surgical Innovations | Nov 14, 1997 | SESE |
| K936186 | AESCULAP SKIN GRAFT MESHER | Aesculap, Inc. | Mar 10, 1994 | SESE |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Inamed Development Co. | Mar 6, 1991 | SESE |
| K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER | Surgitek | Sep 5, 1990 | SESE |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | Mentor Corp. | Aug 26, 1988 | SESE |
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | Dec 2, 1987 | SESE |
Top Applicants
- Aesculap, Inc. — 1 clearance
- Cox-Uphuff Intl. — 1 clearance
- General Surgical Innovations — 1 clearance
- Inamed Development Co. — 1 clearance
- Lb Medical LLC — 1 clearance
