FDA product code · Gastroenterology, Urology · Class 2
FCG: Biopsy Needle
FCG is FDA's product code for "Biopsy Needle": a Class 2 device classified under 21 CFR 876.1075, reviewed by the Gastroenterology, Urology panel.
510(k) review time for FCG
Across 17 510(k) clearances under FCG decided from 2018-01-01 to 2026-10-06, the median was 111 days from FDA receipt to decision. Half took between 90 and 246 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.
| Fastest | 59 |
|---|---|
| 25th percentile | 90 |
| Median | 111 |
| 75th percentile | 246 |
| 80th percentile | 261 |
| 90th percentile | 306 |
| Slowest | 602 |
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.
FCG in the public FDA record
| 510(k) clearances, all years | 133 |
|---|---|
| Device recalls | 54 |
| Establishment listings | 279 |
| GUDID device identifiers | 1,585 |
Counts of records, not of devices or events. Adverse event reports for FCG 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 FCG
No FDA recognized consensus standard cites FCG by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
Related product codes
- KNW Instrument, Biopsy
- FGB Ureteroscope And Accessories, Flexible/Rigid
- KNT Tubes, Gastrointestinal (And Accessories)
- KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FGE Stents, Drains And Dilators For The Biliary Ducts