510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122003Substantially Equivalent

Renew Insert

Renew Medical, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122003 is the FDA 510(k) clearance record for RENEW INSERT, a class II device, cleared for Renew Medical, Inc. on under FDA product code PBP (Rectal Insert). FDA's definition for product code PBP reads: "Acts as a barrier to the passage of fecal matter through the rectum". FDA records list one 510(k) clearance for Renew Medical, Inc. As of , FDA records show no recalls naming K122003.

Clearance record

Decision date
Received
(109 days to decision)
Product code
PBP Rectal Insert
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Renew Medical, Inc. 532 Emerson St., Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBP

Trailing 12 months

FDA records hold no clearances under product code PBP in the trailing twelve months.

FDA records show no clearances under product code PBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260