LRP · Tray, Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | LRP |
|---|---|
| Device Name | Tray, 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.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963723 | LACERATION TRAY | Grand Medical Products | Nov 27, 1996 | SESE |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | Osteotech, Inc. | May 31, 1995 | SESE |
| K940239 | EYE TRAY | Cush Medical Products | Jun 28, 1994 | SEKD |
| K935621 | CUSTOM ENT PACKS | Associated Medical | Mar 30, 1994 | SESE |
| K940646 | ORTHOPEDIC TRAY PRODUCT LINE | Cushindu | Mar 11, 1994 | SEKD |
| K940444 | GENERAL SURGERY TRAY | Cush Medical Products | Mar 7, 1994 | SEKD |
| K922126 | HOSPITAL KIT ENT 1125 | Savoy Medical Supply Co., Inc. | Jan 21, 1993 | SESE |
| K912105 | EYE TRAY | Medical Device Inspection Co., Inc. | Aug 29, 1991 | SESE |
| K903963 | KITS AND TRAYS FOR ONE TIME USE ONLY | Apk Technology | Jul 29, 1991 | SEKD |
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | Apk Technology | Jul 29, 1991 | SEKD |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Angiosystems, Inc. | Feb 6, 1991 | SESE |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | J.J. Skinner, Inc. | Aug 31, 1990 | SESD |
| K890071 | STERILE LACERATION TRAY | Mumtaz I. Malik | Jan 24, 1989 | SESE |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | Aug 18, 1988 | SESE |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | East Texas Lighthouse For the Blind | Jul 18, 1988 | SESE |
| K881095 | KOI(TM) INSTRUMENT TRAYS | CooperVision, Inc. | Apr 6, 1988 | SESE |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Precision Dynamics Corp. | Jan 20, 1988 | SESD |
| K873469 | TODD MEDICAL/SKILLED CARE PRODUCTS | Todd Medical, Inc. | Oct 29, 1987 | SESE |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Advantage Medical Systems, Inc. | Sep 24, 1987 | SESE |
| K873439 | LACERATION TRAY | Ulti-Med Intl., Inc. | Sep 11, 1987 | SESE |
Top Applicants
- Apk Technology — 2 clearances
- Cush Medical Products — 2 clearances
- Advantage Medical Systems, Inc. — 1 clearance
- Angiosystems, Inc. — 1 clearance
- Associated Medical — 1 clearance
