SAWBLADE— 510(k) K863788

Name: FDA 510(k) clearance K863788
Creator: U.S. Food and Drug Administration
Published: 1986-10-14

Substantially Equivalent

Tava Surgical Instruments

FDA 510(k) clearance K863788 for SAWBLADE, Substantially Equivalent on 1986-10-14. Applicant: Tava Surgical Instruments. Device class: 1.

Clearance details

Applicant: Tava Surgical Instruments
Product code: Code GFA
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1986-09-26
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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K971978 — GRAFT HARVESTING SAWBLADES1997-06-18
K954483 — STRYKER SAGITTAL SAW ATTACHMENT1996-01-30
K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES1996-01-18
K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS1995-07-12
K950403 — SURGICAL SAW BLADES1995-02-21

More clearances from Tava Surgical Instruments

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K935367 — TAVA WIRE-DRIVER1994-04-21
K940109 — TAVA K-WIRE1994-02-22
K885273 — MICRO SURGICAL INSTRUMENT SYSTEM1989-01-30
K884492 — MICRO SURGICAL INSTRUMENT SYSTEM1988-11-16
K872475 — SURGICAL BUR1987-07-02

Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.