Product Code: FHP FDA class 2 21 CFR 876.1500

Needle, Pneumoperitoneum, Simple

Gastroenterology, Urology

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.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
5

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K910855 ENDOPATH VERESS NEEDLE
K860102 MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE

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.