510(k) K172598
- Device
- Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
- Applicant
- ITW Contamination Control Electronics
- 510(k) number
- K172598
- Product code
- MLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-19
- Date received
- 2017-08-29
- Regulation
- 510(k) Premarket Notification
- Classification name
- Refrigerant, Topical (vapocoolant)
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Physical Medicine
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steve Cook
- Address
- 8125 Cobb Center Dr. Kennesaw GA US 30152 30152
FDA Registration Numbers#
- 1121142
- 1037559
- 3003775072
- 1417592
- 3014615644
- 3015351183
- 3003925093
- 3005740500
- 3018382913
- 3013034812
- 3010543854
- 3016733629
- 3012448339
- 3021853802
- 2110420
- 1519179
- 3005779557
- 3015177815
- 1420763
Source Documents#
Other 510(k) Records For Product Code MLY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243654 | DentalJect | Vapocoolshot, Inc. | 2025-05-30 |
| K232674 | PainFreeze II | Nuance Medical, LLC | 2024-02-12 |
| K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | 2022-05-25 |
| K202782 | num Vapocoolant | 623 Medical, LLC | 2020-12-21 |
| K201248 | Syringe Holder accessory | Vapocoolshot, Inc. | 2020-08-12 |
| K193349 | Vapocoolshot Mist | Vapocoolshot, Inc. | 2020-04-14 |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray | Gebauer Company | 2019-05-07 |
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | 2017-10-27 |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | 2017-10-18 |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | Nuance Medical, LLC | 2016-11-22 |
| K093951 | OUCHLESS MODEL PN10114 | Occam Design | 2010-06-15 |
| K033720 | ARI COLD SPRAY | Ari | 2005-06-10 |
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | Gebauer Co. | 2004-03-17 |
| K030281 | CRYOTRON 2 CRYOTHERAPY DEVICE | Cryonic Medical North America | 2003-08-20 |
| K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 | Gebauer Co. | 2003-07-10 |
Legacy Summary#
summary
FDA Review#
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