Identifiers
- 510(k) Number
- K902030 FDA 510(k)
- FDA Product Code
- KKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Customed Lap Pack III is a device classified under product code KKX. It received FDA 510(k) clearance as substantially equivalent to a predicate device.
The device was cleared through the traditional 510(k) pathway with review by the General and Plastic Surgery advisory committee. It is manufactured by Customed, Inc. and was granted clearance on July 12, 1990.
Frequently asked questions
What is the Customed Lap Pack III used for?
The Customed Lap Pack III is a laparoscopic surgical pack classified under product code KKX, intended for use in general and plastic surgery procedures as indicated by its FDA 510(k) clearance pathway review.
How was the Customed Lap Pack III cleared for market?
The device received FDA 510(k) clearance through the traditional pathway, with review by the General and Plastic Surgery advisory committee, and was found substantially equivalent to a predicate device on July 12, 1990.
What regulatory identification is associated with the Customed Lap Pack III?
The device is identified by FDA 510(k) number K902030, product code KKX, and was manufactured by Customed, Inc. in Fajardo, Puerto Rico, with clearance granted on July 12, 1990.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CUSTOMED LAP PACK III (K902030) — FDA 510 (k) | Innolitics, PDF K902030 CUSTOMED LAP PACK III - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K902030 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K902030 24 fields · synced Sep 24, 2026