Home / 510(k) Clearances / K931769

510(k) K931769

SNAP OSCILLATING SAW by Surgiquip, Inc. — Product Code GFA

K931769 is an FDA 510(k) premarket notification submitted by Surgiquip, Inc. for the device "SNAP OSCILLATING SAW". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Surgiquip, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
April 9, 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 Surgiquip, Inc.

  • K935517 — SNAP STERNUM SAW (March 10, 1994)
  • K935357 — SNAP RECIPROCATING SAW (January 28, 1994)
  • K935322 — SNAP BONE REAMER (January 28, 1994)
  • K935516 — SNAP DRILL (January 27, 1994)

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

FDA data resources