Trotex II Screw Needle Biopsy Instr. Set
FDA 510(k) K792316 · Ursus Konsult AB
510(k) numberK792316
Submission
- Device name
- Trotex II Screw Needle Biopsy Instr. Set
- Applicant
- Ursus Konsult AB
Mchenry, IL, US - Received
- November 16, 1979
- Decision date
- December 18, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEE – Brush, Biopsy, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K854003 | Sterile Soft Tissue Biopsy NeedleGEE · Traditional | Co-Medical, Inc. | 10/18/1985SE |
| K841008 | Biopsy Punch, VariousGEE · Traditional | Premier Dental Products Co. | 06/08/1984SE |
| K822490 | Deflecting Cytology BrushGEE · Traditional | Van-Tec, Inc. | 09/14/1982SE |
| K820259 | Sterile Cytology BrushesGEE · Traditional | American Endoscopy, Inc. | 03/05/1982SE |
| K812694 | Whisk-RGEE · Traditional | Medi-Spec | 10/26/1981SE |
| K801304 | Camloc Syringe Biopsy KitGEE · Traditional | Johannah Medical Services, Inc. | 06/17/1980SE |
Questions and answers
When was Trotex II Screw Needle Biopsy Instr. Set cleared by the FDA?
Trotex II Screw Needle Biopsy Instr. Set (K792316) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 32 days after the submission was received.
What is the product code of K792316?
The FDA product code is GEE – Brush, Biopsy, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.