Product code NZA— Gastroenterology, Urology
RELIANCE ENDOSCOPE PROCESSING SYSTEM
- Classification name
- Accessories, Germicide, Cleaning, For Endoscopes
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
FDA classification definition
“High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”
Market context for product code NZA
FDA has cleared devices under product code NZA between 1984 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2022
- 2021
- 2020
- 2013
- 2011
- 2010
- 2004
- 1986
- 1984
Top applicants under product code NZA
Recent clearances under product code NZA
- K232918 — enspire 300 Series Automated Endoscope Reprocessor
- K230560 — enspire 300 Series Automated Endoscope Reprocessor System
- K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K203223 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- K200989 — Reliance Endoscope Processing System
- K123768 — RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
- K110453 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
- K841331 — OLYMPUS KC-10 MOBILE DISINFEC-STAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.