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510(k) K881659

TISSUE SECTION ADHESIVE by Surgipath Medical Industries, Inc. — Product Code IFZ

K881659 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "TISSUE SECTION ADHESIVE". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code IFZ (Gelatin For Specimen Adhesion), a Class I device regulated under 21 CFR 864.4010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
April 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gelatin For Specimen Adhesion
Device Class
Class I
Regulation Number
864.4010
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)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 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)

FDA data resources