FDA product code · General, Plastic Surgery · Class 2

FZP: Clip, Implantable

FZP is FDA's product code for "Clip, Implantable": a Class 2 device classified under 21 CFR 878.4300, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.

510(k) review time for FZP

Across 22 510(k) clearances under FZP decided from 2018-01-01 to 2026-10-06, the median was 141 days from FDA receipt to decision. Half took between 59 and 221 days, and 80% were decided within 243 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FZP, decisions 2018-01-01 to 2026-10-06 (n = 22)
Fastest17
25th percentile59
Median141
75th percentile221
80th percentile243
90th percentile302
Slowest787

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.

FZP in the public FDA record

Records naming FZP, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years177
Device recalls45
Establishment listings310
GUDID device identifiers1,264

Counts of records, not of devices or events. Adverse event reports for FZP 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 FZP

No FDA recognized consensus standard cites FZP 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.

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