Home / 510(k) Clearances / K002596

510(k) K002596

GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 by Gebauer Co. — Product Code MLY

K002596 is an FDA 510(k) premarket notification submitted by Gebauer Co. for the device "GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09". The FDA issued a decision of Substantially Equivalent on February 15, 2001. The device falls under product code MLY (Vapocoolant Device), a Class U device. Gebauer Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2001
Date Received
August 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Gebauer Co.

  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
  • K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPR (March 17, 2004)
  • K031036 — GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN (July 10, 2003)
  • K021726 — GEBAUER'S INSTANT ICE (December 12, 2002)
  • K981693 — SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MO (August 6, 2001)
  • K001624 — GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (January 25, 2001)
  • K991514 — GEBAUER'S CHLORIDE FINE NOZZE (July 16, 1999)
  • K930915 — FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE (September 29, 1994)

Other clearances for product code MLY

  • K243654 — DentalJect (May 30, 2025)
  • K232674 — PainFreeze II (February 12, 2024)
  • K203661 — CRYO Arctic, CRYO Penguin (May 25, 2022)
  • K202782 — num Vapocoolant (December 21, 2020)
  • K201248 — Syringe Holder accessory (August 12, 2020)
  • K193349 — Vapocoolshot Mist (April 14, 2020)
  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic (April 19, 2018)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)

FDA data resources