Sigma 1 Wobbler Biopsy Kit
FDA 510(k) K882673 · Kontron Instruments, Inc.
510(k) numberK882673
Submission
- Device name
- Sigma 1 Wobbler Biopsy Kit
- Applicant
- Kontron Instruments, Inc.
Everett, MA, US - Received
- June 28, 1988
- Decision date
- July 28, 1988
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|---|
| K852105 | Manan Ubk Ultrasonic Guided Biopsy KitFCH · Traditional | Manan Manufacturing Co., Inc. | 06/18/1985SESD |
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Questions and answers
When was Sigma 1 Wobbler Biopsy Kit cleared by the FDA?
Sigma 1 Wobbler Biopsy Kit (K882673) received a 510(k) decision of Substantially Equivalent on July 28, 1988, 30 days after the submission was received.
What is the product code of K882673?
The FDA product code is FCH – Tray, Biopsy, Without Biopsy Instruments, a Class I (low risk) device regulated under 21 CFR 876.4730.