Prepacell-Sterile-Bone Marrow Aspir
FDA 510(k) K833438 · Applied Medical Devices, Inc.
510(k) numberK833438
Submission
- Device name
- Prepacell-Sterile-Bone Marrow Aspir
- Applicant
- Applied Medical Devices, Inc.
Mchenry, IL, US - Received
- October 5, 1983
- Decision date
- February 9, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K843885 | Percutaneous Aspiration Biopsy Tray · Traditional | 12/19/1984SE |
| K843884 | General Utility Tray System · Traditional | 12/13/1984SE |
| K843883 | Sterile Percutaneous Transhepatic Cholan · Traditional | 12/13/1984SE |
| K840904 | Accu-Cult Fecal Occult Blood TestKHE · Traditional | 08/16/1984SE |
| K842591 | Ultrasound Probe Covers-SterileIYO · Traditional | 07/23/1984SE |
| K833720 | Transthoracic/Transabdominal-TrayGDM · Traditional | 05/30/1984SE |
| K840334 | Chemonucleolysis/Discography TrayFMI · Traditional | 04/13/1984SE |
| K833719 | Prepacell Thin Needle Aspiration TrayKOD · Traditional | 01/25/1984SE |
| K802406 | Cytotran I Bone Marrow Aspiration SystemFMF · Traditional | 01/15/1981SE |
| K791660 | Prepacell-Bone Marrow SamplerFMF · Traditional | 09/12/1979SE |
Questions and answers
When was Prepacell-Sterile-Bone Marrow Aspir cleared by the FDA?
Prepacell-Sterile-Bone Marrow Aspir (K833438) received a 510(k) decision of Substantially Equivalent on February 9, 1984, 127 days after the submission was received.
What is the product code of K833438?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.