Axicut Disposable Scalpel
FDA 510(k) K811707 · Neonatal Corp.
510(k) numberK811707
Submission
- Device name
- Axicut Disposable Scalpel
- Applicant
- Neonatal Corp.
Mchenry, IL, US - Received
- June 16, 1981
- Decision date
- July 20, 1981
- 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 |
| K880028 | Omed Disposable ScalpelGDX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| 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 |
More from Precision Surgical Industries, Inc.
Questions and answers
When was Axicut Disposable Scalpel cleared by the FDA?
Axicut Disposable Scalpel (K811707) received a 510(k) decision of Substantially Equivalent on July 20, 1981, 34 days after the submission was received.
What is the product code of K811707?
The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.