Needle, Pneumoperitoneum, Simple
The Simple Pneumoperitoneum Needle is a basic design of the Veress-type needle used to insufflate the abdominal cavity with gas in preparation for laparoscopic surgery. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FHP, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FHP
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.