CRYOSURGICAL DEVICE 2000— 510(k) K781956
Substantially EquivalentValleylab, Inc.
FDA 510(k) clearance K781956 for CRYOSURGICAL DEVICE 2000, Substantially Equivalent on 1979-01-10. Applicant: Valleylab, Inc.. Device class: 2.
Clearance details
- Applicant
- Valleylab, 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
- Walker, MI, 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 Valleylab, Inc.
view all- K031011 — LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
- K010010 — VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
- K010013 — LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
- K994428 — E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
- K983743 — BISURE LAPAROSCOPIC BIPOLAR FORCEPS
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.