C2 CryoBalloon Ablation System— 510(k) K212814
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K212814 for C2 CryoBalloon Ablation System, Substantially Equivalent on 2021-11-29. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, 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
- Redwood, Ca, CA, 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 Pentax of America, Inc.
view all- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
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.