Niomed Surgical Hood
FDA 510(k) K954454 · Amerasia Corp.
510(k) numberK954454
Submission
- Device name
- Niomed Surgical Hood
- Applicant
- Amerasia Corp.
Riverside, CA, US - Received
- September 25, 1995
- Decision date
- January 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYF – Cap, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | American Seal Co. | 09/09/1997SE |
| K955833 | Niomed Surgical CapsFYF · Traditional | Amerasia Corp. | 03/15/1996SE |
| K954556 | Surgical CapFYF · Traditional | Thai Disposable Products Co., Ltd. | 03/12/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K953879 | Surgeon's CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K913700 | Disposable Bouffant CapFYF · Traditional | Gem Nonwovews, Inc. | 10/04/1991SE |
| K882346 | Instrument Protect-A-Caps, Aka: Tip/Instru. GuardFYF · Traditional | Nordbye, Milchman, Barlage | 06/30/1988SE |
| K882284 | Surgeons CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
More from A Plus International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955833 | Niomed Surgical CapsFYF · Traditional | 03/15/1996SE |
| K954747 | Niomed Barrier GownsFYC · Traditional | 03/06/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | 01/23/1996SE |
| K952937 | Niomed Non-Skid Shoe CoversFXP · Traditional | 10/23/1995SE |
| K952897 | Niomed Shoe CoversFXP · Traditional | 10/23/1995SE |
Questions and answers
When was Niomed Surgical Hood cleared by the FDA?
Niomed Surgical Hood (K954454) received a 510(k) decision of Substantially Equivalent on January 23, 1996, 120 days after the submission was received.
What is the product code of K954454?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.