Air Assisted Sprayer, Models: AIRSPRAYUS01 and Airsprayus
FDA 510(k) K082322 · Covidien
510(k) numberK082322
Submission
- Device name
- Air Assisted Sprayer, Models: AIRSPRAYUS01 and Airsprayus
- Applicant
- Covidien
Waltham, MA, US - Received
- August 13, 2008
- Decision date
- November 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Air Assisted Sprayer, Models: AIRSPRAYUS01 and Airsprayus cleared by the FDA?
Air Assisted Sprayer, Models: AIRSPRAYUS01 and Airsprayus (K082322) received a 510(k) decision of Substantially Equivalent on November 14, 2008, 93 days after the submission was received.
What is the product code of K082322?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.