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510(k) K801585

HESSBURG-BFRRON TREPHINE by Precision Instruments, Inc. — Product Code EMF

K801585 is an FDA 510(k) premarket notification submitted by Precision Instruments, Inc. for the device "HESSBURG-BFRRON TREPHINE". The FDA issued a decision of Substantially Equivalent on October 3, 1980. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Precision Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1980
Date Received
July 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Precision Instruments, Inc.

  • K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (January 20, 1987)
  • K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (March 25, 1986)
  • K843048 — RING SUPPORTED TREPHINE FOR CORNEA TRANS (October 5, 1984)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (October 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)

FDA data resources