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510(k) K933595

BUR, SURGICAL, GENERAL & PLASTIC SURGERY by Omega Surgical Instruments, Inc. — Product Code GFA

K933595 is an FDA 510(k) premarket notification submitted by Omega Surgical Instruments, Inc. for the device "BUR, SURGICAL, GENERAL & PLASTIC SURGERY". The FDA issued a decision of Substantially Equivalent on March 16, 1994. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Omega Surgical Instruments, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
July 26, 1993
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 Omega Surgical Instruments, Inc.

  • K941434 — K-WIRES AND STEINMANN PINS (October 3, 1994)
  • K933298 — SAW BLADE (August 9, 1993)

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)
  • 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)
  • K934390 — OSCILLATING BONE SAW BLADE, 6200 SERIES (January 26, 1994)

FDA data resources