BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS— 510(k) K933827

Name: FDA 510(k) clearance K933827
Creator: U.S. Food and Drug Administration
Published: 1994-06-30

Substantially Equivalent

Bioplexus Corp.

FDA 510(k) clearance K933827 for BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS, Substantially Equivalent on 1994-06-30. Applicant: Bioplexus Corp.. Device class: 2.

Clearance details

Applicant: Bioplexus Corp.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1993-08-05
Decision date: 1994-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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K952732 — MEDICAL GRADE SILICONE BLOCK1995-08-31
K932176 — BIOSIL MEDICAL GRADE SILICONE SHEETING1993-12-02

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.