Instruments for One Time Use - Disposable
FDA 510(k) K011514 · Kencap , Ltd.
510(k) numberK011514
Submission
- Device name
- Instruments for One Time Use - Disposable
- Applicant
- Kencap , Ltd.
Ringwood, NJ, US - Received
- May 17, 2001
- Decision date
- August 13, 2001
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
| K924117 | Dexide Laparoscopic KitsKDD · Traditional | Dexide, Inc. | 03/23/1993SESK |
Questions and answers
When was Instruments for One Time Use - Disposable cleared by the FDA?
Instruments for One Time Use - Disposable (K011514) received a 510(k) decision of Substantially Equivalent on August 13, 2001, 88 days after the submission was received.
What is the product code of K011514?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.