SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER— 510(k) K902349

Name: FDA 510(k) clearance K902349
Creator: U.S. Food and Drug Administration
Published: 1990-09-05

Substantially Equivalent

Surgitek

FDA 510(k) clearance K902349 for SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER, Substantially Equivalent on 1990-09-05. Applicant: Surgitek. Device class: 1.

Clearance details

Applicant: Surgitek
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-05-25
Decision date: 1990-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, CA, US

Download summary PDF View on FDA.gov ↗

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K984448 — BIRCOLL BALLOON DISSECTOR1999-01-28
K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER1997-11-14
K936186 — AESCULAP SKIN GRAFT MESHER1994-03-10
K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER1991-03-06

More clearances from Surgitek

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K946296 — QUADRA-COIL URETERAL STENT1995-03-06
K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM1995-02-07
K943491 — RIGHT ANGLE UROLOGIC LASER FIBER1994-08-05
K941952 — SURGITEK INFUSER1994-05-24
K933260 — HELICAL STONE/FLATWIRE STONE BASKETS1994-01-11

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.