BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER— 510(k) K865033

Name: FDA 510(k) clearance K865033
Creator: U.S. Food and Drug Administration
Published: 1987-01-12

Substantially Equivalent

Cox-Uphuff Intl.

FDA 510(k) clearance K865033 for BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER, Substantially Equivalent on 1987-01-12. Applicant: Cox-Uphuff Intl.. Device class: Unclassified.

Clearance details

Applicant: Cox-Uphuff Intl.
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1986-12-23
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cox-Uphuff Intl.

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K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER1987-12-02
K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE1987-11-13
K873470 — TEMPLATE1987-09-08
K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER1987-05-22
K871200 — CUI NASAL SEPTUM BUTTON1987-04-15

Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.