P.S.I.-Disposable Metal Handle Surgeons Scalpel
FDA 510(k) K863950 · Precision Surgical Industries, Inc.
510(k) numberK863950
Submission
- Device name
- P.S.I.-Disposable Metal Handle Surgeons Scalpel
- Applicant
- Precision Surgical Industries, Inc.
Scotch Plains, NJ, US - Received
- October 10, 1986
- Decision date
- October 24, 1986
- 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 |
| 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 |
|---|---|---|
| K863951 | P.S.I.-Disposable Scalpel Surgeons HandleGDZ · Traditional | 10/24/1986SE |
Questions and answers
When was P.S.I.-Disposable Metal Handle Surgeons Scalpel cleared by the FDA?
P.S.I.-Disposable Metal Handle Surgeons Scalpel (K863950) received a 510(k) decision of Substantially Equivalent on October 24, 1986, 14 days after the submission was received.
What is the product code of K863950?
The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.