FDA product code · Gastroenterology, Urology · Class 2
FED: Endoscopic Access Overtube, Gastroenterology-Urology
FED is FDA's product code for "Endoscopic Access Overtube, Gastroenterology-Urology": a Class 2 device classified under 21 CFR 876.1500, reviewed by the Gastroenterology, Urology panel.
510(k) review time for FED
Across 43 510(k) clearances under FED decided from 2018-01-01 to 2026-10-06, the median was 111 days from FDA receipt to decision. Half took between 57 and 165 days, and 80% were decided within 204 days. These are past clearances, not a forecast for a new submission.
| Fastest | 21 |
|---|---|
| 25th percentile | 57 |
| Median | 111 |
| 75th percentile | 165 |
| 80th percentile | 204 |
| 90th percentile | 245 |
| Slowest | 492 |
| Year | Median days | n |
|---|---|---|
| 2019 | 94 | 5 |
| 2024 | 98 | 6 |
| 2025 | 120 | 11 |
| 2026 (to 10-06, partial) | 67 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FED in the public FDA record
| 510(k) clearances, all years | 102 |
|---|---|
| Device recalls | 12 |
| Establishment listings | 174 |
| GUDID device identifiers | 716 |
Counts of records, not of devices or events. Adverse event reports for FED are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite FED
1 FDA recognized consensus standard cite FED, among them AAMI ANSI ST108:2023. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-597 AAMI ANSI ST108:2023 — Water for the processing of medical devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.