Omed Disposable Scalpel
FDA 510(k) K880028 · Oxboro Medical Intl., Inc.
510(k) numberK880028
Submission
- Device name
- Omed Disposable Scalpel
- Applicant
- Oxboro Medical Intl., Inc.
Bloomington, MN, US - Received
- January 5, 1988
- Decision date
- January 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDX – Scalpel, One-Piece
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923689 | Surgistar BladesGDX · Traditional | Surgistar, Inc. | 09/09/1992SE |
| K921167 | UltrabladeGDX · Traditional | Micron Technology, Inc. | 07/30/1992SE |
| K914086 | Ican Cylindrical SpongesGDX · Traditional | Icn Pharmaceuticals, Inc. | 10/09/1991SE |
| K904505 | Cci Corneal ScarifierGDX · Traditional | Buckman Co., Inc. | 04/23/1991SE |
| K905380 | 1-CUT Acl Graft KnifeGDX · Traditional | Depuy, Inc. | 12/13/1990SE |
| K895682 | Vessel LoopsGDX · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K893033 | Mini-Diamond KnifeGDX · Traditional | L.A.B. Instruments | 05/26/1989SE |
| K871894 | KCK Industries' Surgical InstrumentsGDX · Traditional | Kck Industries | 06/23/1987SE |
| K863950 | P.S.I.-Disposable Metal Handle Surgeons ScalpelGDX · Traditional | Precision Surgical Industries, Inc. | 10/24/1986SE |
| K863213 | Keisei Scalpel (Sterile and Non-Sterile)GDX · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
More from Keisei Medical Industrial Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K953068 | Oxboro-Medical Foam Instrument HolderKCT · Traditional | 01/23/1996SE |
| K952787 | Foam Instrument GuardKCT · Traditional | 12/28/1995SE |
| K952783 | Oxboro-Medical Pin CoversLRN · Traditional | 09/15/1995SE |
| K952784 | Oxboro-Medical Cautery Tip CleanerHQP · Traditional | 07/13/1995SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | 01/29/1988SE |
Questions and answers
When was Omed Disposable Scalpel cleared by the FDA?
Omed Disposable Scalpel (K880028) received a 510(k) decision of Substantially Equivalent on January 29, 1988, 24 days after the submission was received.
What is the product code of K880028?
The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.