Isi Self-Supporting Arm
FDA 510(k) K925005 · Instrumentation Specialties, Inc.
510(k) numberK925005
Submission
- Device name
- Isi Self-Supporting Arm
- Applicant
- Instrumentation Specialties, Inc.
Boerne, TX, US - Received
- October 2, 1992
- Decision date
- April 29, 1993
- 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 |
|---|---|---|---|
| K942699 | Airframe Surgical Drape SupportBWN · Traditional | Alpha Surgical, Inc. | 07/13/1994SE |
| K935441 | Infinitech Breath EzBWN · Traditional | Infinitech, Inc. | 02/07/1994SE |
| 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 |
|---|---|---|
| K881101 | K Orthopedic TableJEB · Traditional | 04/06/1988SE |
Questions and answers
When was Isi Self-Supporting Arm cleared by the FDA?
Isi Self-Supporting Arm (K925005) received a 510(k) decision of Substantially Equivalent on April 29, 1993, 209 days after the submission was received.
What is the product code of K925005?
The FDA product code is BWN – Table And Attachments, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4950.