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510(k) K863616

KNIFE MAKER by Surgipath Medical Industries, Inc. — Product Code IDL

K863616 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "KNIFE MAKER". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code IDL (Microtome, Accessories), 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 25, 1986
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtome, Accessories
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)
  • K863548 — ROTARY MICROTOME (September 19, 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 IDL

  • K831921 — DISPOSABLE MICROTOME BLADES (July 29, 1983)
  • K831308 — DISPOSABLE MICROTOME BLADE (May 16, 1983)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)
  • K801426 — TISSUE-TEK III MICROJECT DISP. BLADE SYS (July 28, 1980)

FDA data resources