7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1
FDA 510(k) K851751 · Artiberia
510(k) numberK851751
Submission
- Device name
- 7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- June 20, 1985
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
Questions and answers
When was 7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1 cleared by the FDA?
7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1 (K851751) received a 510(k) decision of Substantially Equivalent on June 20, 1985, 56 days after the submission was received.
What is the product code of K851751?
The FDA product code is GDX – Scalpel, One-Piece, a Class I (low risk) device regulated under 21 CFR 878.4800.