FDA product code FDE: Laparoscopy Kit
FDE is the FDA product code for laparoscopy kit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FDE, from 4 different applicants. The average 510(k) review took 63 days (median 59). FDA has posted 124 recalls for FDE devices, 62 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Laparoscopy Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FDE clearance
Top FDE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitsubishi Cable America, Inc. | 1 | 1996-04-18 |
| Aslan Medical Technologies, Ltd. | 1 | 1995-03-14 |
| Boston Scientific Corp | 1 | 1994-07-21 |
| Candela Laser Corp. | 1 | 1991-08-16 |
Most recent FDE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955717 | Mitsubishi Cable America, Inc. | ENDOSCOPE INTRODUCER KIT | 1996-04-18 | 122 |
| K950924 | Aslan Medical Technologies, Ltd. | ASLAN KNOT PUSHER | 1995-03-14 | 13 |
| K942677 | Boston Scientific Corp | GEENEN/ZEBRA GUIDELINES | 1994-07-21 | 44 |
| K912443 | Candela Laser Corp. | CANDELA INTRODUCER SHEATH SYSTEM | 1991-08-16 | 74 |
Recalls for FDE devices
124 product recalls in 63 recall events; 62 initiated in the last five years and 59 still open. Most recent: 2026-08-10.
| Year | Recalls |
|---|---|
| 2020 | 3 |
| 2022 | 9 |
| 2023 | 8 |
| 2024 | 14 |
| 2025 | 16 |
| 2026 | 15 |
Frequently asked questions
What is FDA product code FDE?
FDE is the FDA product code for laparoscopy kit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDE?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FDE?
Across 4 cleared submissions the average was 63 days from receipt to decision (median 59).
Which companies have the most FDE clearances?
Mitsubishi Cable America, Inc. (1); Aslan Medical Technologies, Ltd. (1); Boston Scientific Corp (1); Candela Laser Corp. (1).
Have FDE devices been recalled?
Yes: 124 product recalls across 63 recall events; the most recent began 2026-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code FDE
- Run a recall and safety report across every FDE manufacturer
- Watch product code FDE 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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