Airframe Surgical Drape Support
FDA 510(k) K942699 · Alpha Surgical, Inc.
510(k) numberK942699
Submission
- Device name
- Airframe Surgical Drape Support
- Applicant
- Alpha Surgical, Inc.
Eau Claire, WI, US - Received
- June 8, 1994
- Decision date
- July 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K852332 | Table Accessories, Operating RoomBWN · Traditional | Scholten Surgical Instruments, Inc. | 07/02/1985SE |
More from Scholten Surgical Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951420 | Incase Extensible Bag--Non-SterileLYU · Traditional | 06/08/1995SE |
Questions and answers
When was Airframe Surgical Drape Support cleared by the FDA?
Airframe Surgical Drape Support (K942699) received a 510(k) decision of Substantially Equivalent on July 13, 1994, 35 days after the submission was received.
What is the product code of K942699?
The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.