Manan Ubk Ultrasonic Guided Biopsy Kit
FDA 510(k) K852105 · Manan Manufacturing Co., Inc.
510(k) numberK852105
Submission
- Device name
- Manan Ubk Ultrasonic Guided Biopsy Kit
- Applicant
- Manan Manufacturing Co., Inc.
Skokie, IL, US - Received
- May 15, 1985
- Decision date
- June 18, 1985
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCH – Tray, Biopsy, Without Biopsy Instruments
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882673 | Sigma 1 Wobbler Biopsy KitFCH · Traditional | Kontron Instruments, Inc. | 07/28/1988SE |
More from Kontron Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873208 | Manan Turner Style NeedleKNW · Traditional | 08/25/1987SE |
| K864405 | Manan Contrast Media Administration SetFPA · Traditional | 12/18/1986SE |
| K863848 | Manan Brest Tumor Localization NeedleGAA · Traditional | 10/14/1986SE |
| K852501 | Myelogram Procedure Tray · Traditional | 07/11/1985SESD |
| K852018 | Arthrogram Tray for Double & Single Contrast Arthr · Traditional | 07/11/1985SESD |
| K851834 | Manan Gwi Guide Wire IntroducerDWS · Traditional | 07/11/1985SE |
| K851833 | Manan Seldinger NeedleDWS · Traditional | 07/11/1985SE |
| K851832 | Naman Potts Cournand NeedleDWS · Traditional | 07/11/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | 06/27/1985SE |
| K852427 | Manan Spinal NeedleGAA · Traditional | 06/27/1985SE |
Questions and answers
When was Manan Ubk Ultrasonic Guided Biopsy Kit cleared by the FDA?
Manan Ubk Ultrasonic Guided Biopsy Kit (K852105) received a 510(k) decision of Unknown on June 18, 1985, 34 days after the submission was received.
What is the product code of K852105?
The FDA product code is FCH – Tray, Biopsy, Without Biopsy Instruments, a Class I (low risk) device regulated under 21 CFR 876.4730.