Tidal Distension Irrigation Set
FDA 510(k) K841362 · Abbott Laboratories
510(k) numberK841362
Submission
- Device name
- Tidal Distension Irrigation Set
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 2, 1984
- Decision date
- August 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Tidal Distension Irrigation Set cleared by the FDA?
Tidal Distension Irrigation Set (K841362) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 122 days after the submission was received.
What is the product code of K841362?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.