Ackrad Incision & Drain Set
FDA 510(k) K813103 · Ackrad Laboratories
510(k) numberK813103
Submission
- Device name
- Ackrad Incision & Drain Set
- Applicant
- Ackrad Laboratories
Mchenry, IL, US - Received
- November 3, 1981
- Decision date
- December 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K021272 | Sib Catheter, Model 61-7005LKF · Special | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | 04/24/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | 04/16/2002SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/08/1996SE |
| K952542 | Ackrad Esophageal Balloon Catheter SetBZC · Traditional | 04/23/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | 04/23/1996SE |
| K953034 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/29/1995SE |
| K915813 | Ackrad Ercp Contrast Delivery SetFGE · Traditional | 03/11/1992SE |
| K904499 | Nicos (Non-Invasive Cardiac Output System)KFG · Traditional | 07/01/1991SE |
Questions and answers
When was Ackrad Incision & Drain Set cleared by the FDA?
Ackrad Incision & Drain Set (K813103) received a 510(k) decision of Substantially Equivalent on December 9, 1981, 36 days after the submission was received.
What is the product code of K813103?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.