KAM · Cannula, Sinus
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | KAM |
|---|---|
| Device Name | Cannula, Sinus |
| 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 (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110687 | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | Acclarent, Inc. | Oct 7, 2011 | SESE |
| K093594 | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | Mar 3, 2010 | SESE |
| K083574 | RELIEVA STRATUS MICROFLOW SPACER | Acclarent, Inc. | Jan 29, 2009 | SESE |
| K072891 | SINUS SPACER | Acclarent, Inc. | Mar 19, 2008 | SESE |
| K073041 | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | Acclarent, Inc. | Mar 11, 2008 | SESE |
| K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | Acclarent, Inc. | Sep 28, 2007 | SESE |
| K062458 | ETHMOID SINUS SPACER | Acclarent, Inc. | Sep 15, 2006 | SESE |
| K060974 | RELIENT NAVIGATION DEVICE | Acclarent, Inc. | May 5, 2006 | SESE |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | Apr 27, 2005 | SESE |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Xomed, Inc. | Feb 8, 2000 | SESE |
| K973273 | XOMED T-STENT, FRONTAL SINUS STENT | Xomed, Inc. | Sep 29, 1997 | SESE |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | May 11, 1995 | SESE |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | Apr 4, 1995 | SESE |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | Atos Medical AB | Feb 21, 1995 | SESE |
| K922902 | SALMAN SINUS BUTTON | Boston Medical Products, Inc. | May 18, 1993 | SESE |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | Atos Medical AB | Jan 21, 1993 | SESE |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | Micromedics, Inc. | Dec 20, 1991 | SESE |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | Atos Medical AB | Jun 6, 1990 | SESE |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | Xomed, Inc. | Jan 12, 1982 | SESE |
Top Applicants
- Acclarent, Inc. — 8 clearances
- Xomed, Inc. — 3 clearances
- Atos Medical AB — 3 clearances
- Smith & Nephew Richards, Inc. — 2 clearances
- Micromedics, Inc. — 2 clearances
