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510(k) K834170

OP-CON SURG. INSTRUMENT #10 by Imm Enterprises , Ltd. — Product Code GWZ

K834170 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "OP-CON SURG. INSTRUMENT #10". The FDA issued a decision of Substantially Equivalent on February 23, 1984. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1984
Date Received
November 21, 1983
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 by Imm Enterprises , Ltd.

  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)

Other clearances for product code GWZ

  • K891571 — PERCUSSION HAMMER (March 31, 1989)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K851748 — 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE (June 13, 1985)
  • K840314 — CAT 10-NEUROLOGY DEVICE (February 23, 1984)
  • K834178 — H.R. JAKOBI SURG. INSTR. #10 34/36 (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