Guide to the Knee
FDA 510(k) K843121 · Dyonics, Inc.
510(k) numberK843121
Submission
- Device name
- Guide to the Knee
- Applicant
- Dyonics, Inc.
Mchenry, IL, US - Received
- August 8, 1984
- Decision date
- September 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWN – Table And Attachments, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
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| K925005 | Isi Self-Supporting ArmBWN · Traditional | Instrumentation Specialties, Inc. | 04/29/1993SE |
| K922288 | Holder, Pediatric PositionBWN · Traditional | Yamashita and Hemsley Business Trust | 02/10/1993SE |
| K910783 | Shampaine Model 3800 or Muranaka Model OR-604MBWN · Traditional | Smith & Nephew Equipment Group | 04/02/1991SE |
| K902865 | Baumer Surgical TableBWN · Traditional | Sds Dental, Inc. | 09/10/1990SE |
| K884558 | Iop Adjustable StirrupBWN · Traditional | Mend Technologies, Inc. | 11/17/1988SE |
| K875291 | Spinal Surgery FrameBWN · Traditional | T. Korossurgical Instruments Corp. | 01/22/1988SE |
| K873272 | Endoscopy Table 1532 EndostarBWN · Traditional | Stierlen-Maquet AG | 09/08/1987SE |
| K860177 | Allen Universal StirrupBWN · Traditional | Edgewater Medical Equipment Systems | 02/11/1986SE |
More from Edgewater Medical Equipment Systems
| 510(k) | Device | Decision |
|---|---|---|
| K900070 | Modified Uses of the Arthroscopic Surgical SystemHRX · Traditional | 02/16/1990SE |
| K896416 | Dyonics Shoulder Portal SystemHRX · Traditional | 01/02/1990SE |
| K893136 | Surgi-Pak for Arthroscopic AcromioplastyHRX · Traditional | 12/14/1989SE |
| K890665 | Modified Cannula, Trocar and Obturator AccessoriesHRX · Traditional | 11/03/1989SE |
| K894728 | Dyonics Disposable Arthroscopic Surgical KnifeHRX · Traditional | 08/18/1989SE |
| K892062 | PS3500 Arthroscopic Surgical SystemHRX · Traditional | 06/23/1989SE |
| K884839 | Modified Saw Blades to the Sagital SawKIJ · Traditional | 12/07/1988SE |
| K881876 | Dynamic Cruciate TesterLYH · Traditional | 11/17/1988SE |
| K880739 | Dyonics Drill Guide/Isometer SystemLXI · Traditional | 03/21/1988SE |
| K880150 | Pacesetter (TM) 3500 Arthroscopic Surgical SystemHWE · Traditional | 03/04/1988SE |
Questions and answers
When was Guide to the Knee cleared by the FDA?
Guide to the Knee (K843121) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 30 days after the submission was received.
What is the product code of K843121?
The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.