Home / 510(k) Clearances / K812438

510(k) K812438

SAGITTAL SAW by Black & Decker(Tm) — Product Code GEY

K812438 is an FDA 510(k) premarket notification submitted by Black & Decker(Tm) for the device "SAGITTAL SAW". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Black & Decker(Tm) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
August 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Black & Decker(Tm)

  • K820351 — CAST CUTTER/CAST SAW/INSTRUMENT (March 2, 1982)
  • K812439 — DUAL MPC CHARGER (November 2, 1981)
  • K812436 — 450/800 DRILL (November 2, 1981)
  • K812437 — 150 DRIVER REAMER (November 2, 1981)
  • K812440 — POWER PACK (November 2, 1981)
  • K800314 — POWER PACK (March 19, 1980)
  • K800315 — DUAL MPC CHARGER (March 19, 1980)
  • K800313 — SAGITTAL SAW (February 22, 1980)
  • K800312 — 150 DRIVER/REAMER (February 22, 1980)
  • K800311 — 450 DRILL/800 DRILL (February 22, 1980)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)

FDA data resources