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510(k) K861201

FORMALDEHYDE SOLUTION, 37% by Surgipath Medical Industries, Inc. — Product Code IGG

K861201 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "FORMALDEHYDE SOLUTION, 37%". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code IGG (Formaldehyde (Formalin, Formol)), 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 11, 1986
Date Received
March 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formaldehyde (Formalin, Formol)
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)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 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)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)

Other clearances for product code IGG

  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K811794 — 37% FORMALDEHYDE (July 28, 1981)
  • K802506 — PLEASCENT OR FORMA-SCENT (November 12, 1980)
  • K792707 — PARA-PAK SAF (January 21, 1980)
  • K792705 — PARA-PAK FORMALIN (January 21, 1980)
  • K771201 — FORMALIN BUFFER CONCENTRATE (August 22, 1977)

FDA data resources