Amsco Orthographic 2 Table
FDA 510(k) K823772 · American Sterilizer Co.
510(k) numberK823772
Submission
- Device name
- Amsco Orthographic 2 Table
- Applicant
- American Sterilizer Co.
Mchenry, IL, US - Received
- December 14, 1982
- Decision date
- January 14, 1983
- 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
Other 510(k)s with product code BWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942699 | Airframe Surgical Drape SupportBWN · Traditional | Alpha Surgical, Inc. | 07/13/1994SE |
| K935441 | Infinitech Breath EzBWN · Traditional | Infinitech, Inc. | 02/07/1994SE |
| 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 |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
Questions and answers
When was Amsco Orthographic 2 Table cleared by the FDA?
Amsco Orthographic 2 Table (K823772) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 31 days after the submission was received.
What is the product code of K823772?
The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.