KDD · Kit, Surgical Instrument, Disposable
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | KDD |
|---|---|
| Device Name | Kit, Surgical Instrument, Disposable |
| 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 62)
Showing 20 most recent of 62 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | Apr 16, 2008 | SESE |
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | Aug 13, 2001 | SESE |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | May 8, 1997 | SESE |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | Apr 1, 1996 | SESE |
| K936255 | CUSTOM CV PACK | Associated Medical | Mar 31, 1994 | SN |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | Jul 9, 1993 | SESK |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | Jun 17, 1993 | SESE |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | Jun 16, 1993 | SESK |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | Jun 7, 1993 | SEKD |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | Jun 1, 1993 | SEKD |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | Mar 23, 1993 | SESK |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | Oct 19, 1992 | SEKD |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | Sep 28, 1992 | SESK |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | Apr 16, 1992 | SEKD |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | Feb 24, 1992 | SEKD |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | Sep 11, 1991 | SESE |
| K911606 | BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES | Baxter Healthcare Corp | Jul 9, 1991 | SESK |
| K910816 | IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE | Insight International, Inc. | Apr 17, 1991 | SESK |
| K910369 | INCISION AND DRAINAGE KIT | Megadyne Medical Products, Inc. | Mar 28, 1991 | SESE |
| K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT | Megadyne Medical Products, Inc. | Mar 28, 1991 | SESE |
Top Applicants
- Ulti-Med Intl., Inc. — 3 clearances
- Pro-Pak — 3 clearances
- American Medical Disposable, Inc. — 3 clearances
- Pollak (Intl.), Ltd. — 2 clearances
- Megaplast, Inc. — 2 clearances
