KDD — Kit, Surgical Instrument, Disposable Class I
FDA product code KDD covers "Kit, Surgical Instrument, Disposable", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDD
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K072814 | covidien | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA | April 16, 2008 |
| K011514 | kencap | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | August 13, 2001 |
| K971317 | national healthcare mfg | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | May 8, 1997 |
| K960456 | denver biomaterials | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN | April 1, 1996 |
| K936255 | associated medical | CUSTOM CV PACK | March 31, 1994 |
| K932219 | associated medical products | SUTURE SET OR LACERATION TRAYS (PACKS) | July 9, 1993 |
| K923176 | ulti-med intl | SURGICAL INSTRUMENT KIT, DISPOSABLE | June 17, 1993 |
| K925905 | kay medical concepts | KIT, SURGICAL INSTRUMENT, DISPOSABLE | June 16, 1993 |
| K924958 | medical insights | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | June 7, 1993 |
| K925215 | american healthcare supply co | STERILE SURGICAL INSTRUMENT TRAYS | June 1, 1993 |
| K924117 | dexide | DEXIDE LAPAROSCOPIC KITS | March 23, 1993 |
| K920989 | ulti-med intl | SURGICAL INSTRUMENT KIT, DISPOSABLE | October 19, 1992 |
| K920763 | sterile concepts | LACERATTION TRAY | September 28, 1992 |
| K920516 | trinity laboratories | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | April 16, 1992 |
| K914244 | ulti-med intl | STERILE CUSTOM SURGICAL KITS | February 24, 1992 |
| K913049 | macbrud corp. medical div | SLIP-PRUF-CLINGER | September 11, 1991 |
| K911606 | baxter healthcare | BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES | July 9, 1991 |
| K910816 | insight international | IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE | April 17, 1991 |
| K910366 | megadyne medical products | MEGA GENERAL PURPOSE INSTRUMENT KIT | March 28, 1991 |
| K910369 | megadyne medical products | INCISION AND DRAINAGE KIT | March 28, 1991 |