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510(k) K891571

PERCUSSION HAMMER by Sandal Surgico — Product Code GWZ

K891571 is an FDA 510(k) premarket notification submitted by Sandal Surgico for the device "PERCUSSION HAMMER". The FDA issued a decision of Substantially Equivalent on March 31, 1989. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor
Device Class
Class I
Regulation Number
882.1700
Review Panel
NE
Submission Type

Other clearances for product code GWZ

  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K851748 — 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE (June 13, 1985)
  • K834178 — H.R. JAKOBI SURG. INSTR. #10 34/36 (February 23, 1984)
  • K840314 — CAT 10-NEUROLOGY DEVICE (February 23, 1984)
  • K834170 — OP-CON SURG. INSTRUMENT #10 (February 23, 1984)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K803148 — CONPHAR PERCUSSION HAMMER(TAYLOR) (January 8, 1981)
  • K803174 — CONPHAR PERCUSSION HAMMER(BUCK TYPE) (December 30, 1980)
  • K791337 — TAYLOR NEUROLOGICAL HAMMER (August 3, 1979)
  • K791336 — BUCKS NEUROLOGICAL HAMMER (August 3, 1979)

FDA data resources