Product Code: NKC FDA class 1 21 CFR 884.1730

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Obstetrics/Gynecology

The Laparoscopic Insufflation Tubing/Tubing with Filter is a Class 1 obstetrics and gynecology accessory device used to deliver insufflation gas (typically CO2) into the abdominal cavity during laparoscopic procedures, with an optional filter component to ensure gas purity. It is classified as FDA Class 1 (General Controls), under product code NKC and regulation 21 CFR 884.1730 in the Obstetrics and Gynecology specialty. The device is not an implant and is not life-sustaining.

510(k)s
0
FEI Numbers
97
Registration Numbers
97
Unique Applicants
0
Years Active

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Basic Information

Product Code
NKC
Device Class
FDA class 1
Regulation Number
884.1730
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
Submission Type
4

Device Characteristics

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

FEI Numbers

This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.