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510(k) K854192

ANADIAS NASAL SAW BLADES by Anadias, Inc. — Product Code GFA

K854192 is an FDA 510(k) premarket notification submitted by Anadias, Inc. for the device "ANADIAS NASAL SAW BLADES". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Anadias, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
October 15, 1985
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 Anadias, Inc.

  • K871190 — ANADIAS ZARA SYSTEM MALAR IMPLANTS (April 10, 1987)

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