MENTOR RAPID-SPAN (TM) TISSUE EXPANDER— 510(k) K883303

Name: FDA 510(k) clearance K883303
Creator: U.S. Food and Drug Administration
Published: 1988-08-26

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K883303 for MENTOR RAPID-SPAN (TM) TISSUE EXPANDER, Substantially Equivalent on 1988-08-26. Applicant: Mentor Corp.. Device class: 1.

Clearance details

Applicant: Mentor Corp.
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-08-04
Decision date: 1988-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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K936186 — AESCULAP SKIN GRAFT MESHER1994-03-10
K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER1991-03-06

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K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT2004-11-09
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Adverse events under product code FZW

product code FZW

Malfunction: 3,067
Total: 3,067

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.