Dexide Laparoscopic Kits
FDA 510(k) K924117 · Dexide, Inc.
510(k) numberK924117
Submission
- Device name
- Dexide Laparoscopic Kits
- Applicant
- Dexide, Inc.
Fort Worth, TX, US - Received
- August 14, 1992
- Decision date
- March 23, 1993
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
More from American Healthcare Supply Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991814 | Multachoice InstrumentsGEI · Special | 06/23/1999SE |
| K990379 | Modification to Multaport Cannula, Reducer and AccessoriesGCJ · Special | 03/04/1999SE |
| K981940 | Multapump Disposable Pump Head and AccessoriesGCJ · Traditional | 09/25/1998SE |
| K981941 | Multaport Cannula Reducer and AccessoriesGCJ · Traditional | 07/29/1998SE |
| K953611 | Dexide Endo-Lube KitGCJ · Traditional | 09/15/1995SE |
| K944509 | Dexide Insufflation Tubing with FilterHIF · Traditional | 02/07/1995SE |
| K923845 | Dexide Laparoscopic AccessoriesGEI · Traditional | 11/25/1992SE |
| K921709 | Endobag, ModificationGCJ · Traditional | 07/14/1992SE |
| K913762 | Monoscopy(Tm) Brand, EndobagGCJ · Traditional | 10/28/1991SE |
| K912637 | Laparoscopic Electrosurgical Cannula W/RetractableGEI · Traditional | 10/04/1991SE |
Questions and answers
When was Dexide Laparoscopic Kits cleared by the FDA?
Dexide Laparoscopic Kits (K924117) received a 510(k) decision of Unknown on March 23, 1993, 221 days after the submission was received.
What is the product code of K924117?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.