FDA product code FCH: Tray, Biopsy, Without Biopsy Instruments
FCH is the FDA product code for tray, biopsy, without biopsy instruments. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FCH, from 2 different applicants. The average 510(k) review took 32 days (median 32). FDA has posted 14 recalls for FCH devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCH clearance
Top FCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kontron Instruments, Inc. | 1 | 1988-07-28 |
| Manan Manufacturing Co., Inc. | 1 | 1985-06-18 |
Most recent FCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882673 | Kontron Instruments, Inc. | SIGMA 1 WOBBLER BIOPSY KIT | 1988-07-28 | 30 |
| K852105 | Manan Manufacturing Co., Inc. | MANAN UBK ULTRASONIC GUIDED BIOPSY KIT | 1985-06-18 | 34 |
Recalls for FCH devices
14 product recalls in 12 recall events; 10 initiated in the last five years and 9 still open. Most recent: 2025-09-04.
| Year | Recalls |
|---|---|
| 2022 | 4 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FCH?
FCH is the FDA product code for tray, biopsy, without biopsy instruments. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FCH?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCH?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most FCH clearances?
Kontron Instruments, Inc. (1); Manan Manufacturing Co., Inc. (1).
Have FCH devices been recalled?
Yes: 14 product recalls across 12 recall events; the most recent began 2025-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FCH
- Run a recall and safety report across every FCH manufacturer
- Watch product code FCH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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