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510(k) K950403

SURGICAL SAW BLADES by Transidyne General Corp. — Product Code GFA

K950403 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "SURGICAL SAW BLADES". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Transidyne General Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
January 31, 1995
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 Transidyne General Corp.

  • K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
  • K955658 — LACERATION TRAY (January 25, 1996)
  • K950773 — PROPHYLAXIS PACK (March 31, 1995)
  • K950743 — ORAL PROCEDURE PACK (March 31, 1995)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)
  • K897133 — MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (March 30, 1990)

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

FDA data resources