Specimen Trap
FDA 510(k) K834467 · Microvasive
510(k) numberK834467
Submission
- Device name
- Specimen Trap
- Applicant
- Microvasive
Mchenry, IL, US - Received
- December 20, 1983
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYZ – Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | Electromedics, Inc. | 02/05/1993SE |
| K913643 | Mucous Specimen TrapBYZ · Traditional | Medical Device Inspection Co., Inc. | 10/10/1991SE |
| K902883 | Tissue/Polyp Trap SystemBYZ · Traditional | Triton Technology, Inc. | 09/12/1990SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | Delta Medical Industries | 04/05/1984SE |
| K822557 | Specimen AdaptorBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K822556 | Critical Measurement UnitBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K791847 | Aspri-LukeBYZ · Traditional | Medical Marketing Group | 10/02/1979SE |
More from Medical Marketing Group
| 510(k) | Device | Decision |
|---|---|---|
| K872771 | Low Profile GastrostomyKNT · Traditional | 10/09/1987SE |
| K870705 | Thermal CoagulatorKNS · Traditional | 04/17/1987SE |
| K861323 | Replacement Gastrostomy TubeKNT · Traditional | 12/16/1986SE |
| K861309 | Jejunal Feeding TubeKNT · Traditional | 12/16/1986SE |
| K860589 | Inflator/Deflator Piston SyringeKNT · Traditional | 04/07/1986SE |
| K860366 | Challenger Hot Biopsy ForcepsKNS · Traditional | 04/07/1986SE |
| K854238 | Needle W/Stylet for ImplantationGAA · Traditional | 11/13/1985SE |
| K854063 | Microvasive Silicone SprayKCT · Traditional | 10/25/1985SE |
| K851652 | PapillotomeKNS · Traditional | 06/24/1985SE |
| K850393 | Flexible Fiberoptic Endoscope · Traditional | 06/04/1985SE |
Questions and answers
When was Specimen Trap cleared by the FDA?
Specimen Trap (K834467) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 59 days after the submission was received.
What is the product code of K834467?
The FDA product code is BYZ – Trap, Sterile Specimen, a Class II (moderate risk) device regulated under 21 CFR 880.6740.