CMS CRYOLITE— 510(k) K970995
Substantially EquivalentCryomedical Sciences, Inc.
FDA 510(k) clearance K970995 for CMS CRYOLITE, Substantially Equivalent on 1997-07-07. Applicant: Cryomedical Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Cryomedical Sciences, Inc.
- Product code
- Code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code GEH
view all- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
More clearances from Cryomedical Sciences, Inc.
view all- K011073 — CRYOPLAN SYSTEM
- K982055 — ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
- K980668 — CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
- K980670 — CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
- K973190 — ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.