510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003956Substantially Equivalent

Bard Endocinch Suturing System # 000452; 000454; 000595

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003956 is the FDA 510(k) clearance record for BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595, a class II device, cleared for C.R. Bard, Inc. on under FDA product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)). FDA's definition for product code ODE reads: "To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant". FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K003956.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 129 Concord Rd., Billerica MA
510(k) summary
Summary
Third party review
Yes

Clearances, product code ODE

Trailing 12 months

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

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