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510(k) K863788

SAWBLADE by Tava Surgical Instruments — Product Code GFA

K863788 is an FDA 510(k) premarket notification submitted by Tava Surgical Instruments for the device "SAWBLADE". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Tava Surgical Instruments has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Saw, General & Plastic Surgery, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Tava Surgical Instruments

  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)
  • K940109 — TAVA K-WIRE (February 22, 1994)
  • K885273 — MICRO SURGICAL INSTRUMENT SYSTEM (January 30, 1989)
  • K884492 — MICRO SURGICAL INSTRUMENT SYSTEM (November 16, 1988)
  • K872475 — SURGICAL BUR (July 2, 1987)
  • K854543 — PULSE LAVAGE (January 27, 1986)

Other clearances for product code GFA

  • K971978 — GRAFT HARVESTING SAWBLADES (June 18, 1997)
  • K954483 — STRYKER SAGITTAL SAW ATTACHMENT (January 30, 1996)
  • K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES (January 18, 1996)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K940501 — RE-SHARPENABLE SAW BLADES (June 28, 1994)
  • K933595 — BUR, SURGICAL, GENERAL & PLASTIC SURGERY (March 16, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934603 — SURGICAL SAW BLADES (February 22, 1994)
  • K931769 — SNAP OSCILLATING SAW (January 27, 1994)

FDA data resources