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510(k) K863548

ROTARY MICROTOME by Surgipath Medical Industries, Inc. — Product Code IDO

K863548 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "ROTARY MICROTOME". The FDA issued a decision of Substantially Equivalent on September 19, 1986. The device falls under product code IDO (Microtome, Rotary), a Class I device regulated under 21 CFR 864.3010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1986
Date Received
September 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtome, Rotary
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Surgipath Medical Industries, Inc.

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K881921 — C-E BRUSH (July 19, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 1986)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)

Other clearances for product code IDO

  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K843505 — LKB 2230 ROTARY ONE (November 30, 1984)
  • K812558 — TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (September 29, 1981)
  • K812157 — LKB-BROMMA 2218 HISTORANGE MICROTOME (August 18, 1981)

FDA data resources