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

Rectal Insert

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PBP is the FDA product code for Rectal Insert, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "Acts as a barrier to the passage of fecal matter through the rectum". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PBP
Device name
Rectal Insert
FDA definition
Acts as a barrier to the passage of fecal matter through the rectum.
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PBP

By decision year
2 clearances under product code PBP with a decision year between 2012 and 2025, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PBP by decision year
YearClearances
20121
20251

Applicants with the most clearances

Product code PBP
Applicants holding the most 510(k) clearances under product code PBP
ApplicantClearances
Minnesota Medical Technologies1
Renew Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code