Instruments for One Time Use/ Disposable
FDA 510(k) K903962 · Apk Technology
510(k) numberK903962
Submission
- Device name
- Instruments for One Time Use/ Disposable
- Applicant
- Apk Technology
Israel, IL - Received
- August 28, 1990
- Decision date
- July 29, 1991
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRP – Tray, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963723 | Laceration TrayLRP · Traditional | Grand Medical Products | 11/27/1996SE |
| K951811 | Osteotech Musculoskeletal Tissue Recovery PackLRP · Traditional | Osteotech, Inc. | 05/31/1995SE |
| K940239 | Eye TrayLRP · Traditional | Cush Medical Products | 06/28/1994SEKD |
| K935621 | Custom ENT PacksLRP · Traditional | Associated Medical | 03/30/1994SE |
| K940646 | Orthopedic Tray Product LineLRP · Traditional | Cushindu | 03/11/1994SEKD |
| K940444 | General Surgery TrayLRP · Traditional | Cush Medical Products | 03/07/1994SEKD |
| K922126 | Hospital Kit ENT 1125LRP · Traditional | Savoy Medical Supply Co., Inc. | 01/21/1993SE |
| K912105 | Eye TrayLRP · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | Apk Technology | 07/29/1991SEKD |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | Angiosystems, Inc. | 02/06/1991SE |
More from Angiosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250425 | Ultraviolet Phototherapy DeviceFTC · Traditional | 04/07/2025SE |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 SensorsDQA · Traditional | 06/08/2018SE |
| K170536 | ECG Disposable Lead WireDSA · Traditional | 04/24/2017SE |
| K102825 | Blood Pressure CuffDXQ · Traditional | 03/02/2011SE |
| K082846 | Apk SPO2 Pulse Oximeter SensorDQA · Traditional | 04/03/2009SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | 07/29/1991SEKD |
Questions and answers
When was Instruments for One Time Use/ Disposable cleared by the FDA?
Instruments for One Time Use/ Disposable (K903962) received a 510(k) decision of Unknown on July 29, 1991, 335 days after the submission was received.
What is the product code of K903962?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.