FSP · Loupe, Diagnostic/Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FSP |
|---|---|
| Device Name | Loupe, Diagnostic/Surgical |
| 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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895248 | IMS5000 ILLUMINATED LOUPES | Luxtec Corp. | Sep 15, 1989 | SESE |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | Luxtec Corp. | Nov 17, 1986 | SESE |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | May 23, 1986 | SESE |
Top Applicants
- Luxtec Corp. — 2 clearances
- Zinnanti Surgical Instruments, Inc. — 1 clearance
- Keeler Instruments, Inc. — 1 clearance
