CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680— 510(k) K964336
Substantially EquivalentCryomedical Sciences, Inc.
FDA 510(k) clearance K964336 for CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680, Substantially Equivalent on 1997-03-20. 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.