INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER— 510(k) K904265

Name: FDA 510(k) clearance K904265
Creator: U.S. Food and Drug Administration
Published: 1991-03-06

Substantially Equivalent

Inamed Development Co.

FDA 510(k) clearance K904265 for INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER, Substantially Equivalent on 1991-03-06. Applicant: Inamed Development Co.. Device class: 1.

Clearance details

Applicant: Inamed Development Co.
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-09-18
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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K936186 — AESCULAP SKIN GRAFT MESHER1994-03-10
K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER1990-09-05

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K931548 — INAMED DEVELOPMENT ASPIRATION TIP1994-01-10
K901742 — INAMED SMALL DRAIN SYSTEM1990-05-07
K901764 — INAMED CONVERTIBLE DRAIN SYSTEM1990-05-07
K894618 — INAMED RHEMO-D (TM) DILATOR1990-01-18
K896491 — INAMED CLOSED-WOUND DRAIN SYSTEM1990-01-08

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.