SURGICOT STEAM TEST PACK— 510(k) K854902
Substantially EquivalentSurgicot, Inc.
FDA 510(k) clearance K854902 for SURGICOT STEAM TEST PACK, Substantially Equivalent on 1986-05-20. Applicant: Surgicot, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgicot, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Smithtown, NY, US
Recent devices under product code FRC
view allMore clearances from Surgicot, Inc.
view allRecalls naming K854902
K-number listed on FDA's recall record- Z-1793-2022 — a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.
- Z-0605-2014 — VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K854902.
Data sourced from openFDA. This site is unofficial and independent of the FDA.