SOFT TISSUE AUGMENTATION TUBE— 510(k) K960481

Name: FDA 510(k) clearance K960481
Creator: U.S. Food and Drug Administration
Published: 1996-04-01

Substantially Equivalent

Tissue Technologies, Inc.

FDA 510(k) clearance K960481 for SOFT TISSUE AUGMENTATION TUBE, Substantially Equivalent on 1996-04-01. Applicant: Tissue Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tissue Technologies, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1996-02-02
Decision date: 1996-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tissue Technologies, Inc.

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K002071 — SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES2000-07-24
K000849 — SOFTFORM FACIAL IMPLANT2000-05-19
K982475 — SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL1998-09-22
K973462 — SOFTFORM FACIAL IMPLANT1997-11-24
K970804 — TRU-PULSE CO2 SURGICAL LASER1997-06-03

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.