510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FAPClass II

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

21 CFR 876.1620 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAP is the FDA product code for Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, a class II device type, regulated under 21 CFR 876.1620. As of , FDA records hold 85 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
FAP
Device name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
85
Ingested recalls
6

Clearances, product code FAP

By decision year
85 clearances under product code FAP with a decision year between 1977 and 2012, 1992 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code FAP by decision year
YearClearances
19772
19798
19802
19811
19824
19832
19842
198510
19869
19871
19883
19892
19906
199110
199213
19935
19941
19961
19971
19981
20121

Applicants with the most clearances

Product code FAP
Applicants holding the most 510(k) clearances under product code FAP
ApplicantClearances
Life-Tech Intl., Inc.14
Browne Corp.7
Browne Medical Systems, Inc.7
Dantec Medical, Inc.6
Warne Surgical Products, Ltd.4
Dantec Electronics, Inc.3
Diagnostic Ultrasound Corp.3
Biosearch Medical Products, Inc.2
Browne Medical, Inc.2
Cook Incorporated2

Companies listing this code with FDA

Companies whose registered establishments list this code