1-CUT Acl Graft Knife
FDA 510(k) K905380 · Depuy, Inc.
510(k) numberK905380
Submission
- Device name
- 1-CUT Acl Graft Knife
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- November 30, 1990
- Decision date
- December 13, 1990
- 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
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| 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 |
| 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 |
| K863213 | Keisei Scalpel (Sterile and Non-Sterile)GDX · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
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Questions and answers
When was 1-CUT Acl Graft Knife cleared by the FDA?
1-CUT Acl Graft Knife (K905380) received a 510(k) decision of Substantially Equivalent on December 13, 1990, 13 days after the submission was received.
What is the product code of K905380?
The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.