510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231603Substantially Equivalent

Standard Staple-Line Reinforcement (SSLR23)

Standard Bariatrics, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231603 is the FDA 510(k) clearance record for Standard Staple-Line Reinforcement (SSLR23), a class II device, cleared for Standard Bariatrics, Inc. on under FDA product code OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement). FDA's definition for product code OXC reads: "For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures". FDA records list 12 510(k) clearances for Standard Bariatrics, Inc., from to . As of , FDA records show no recalls naming K231603.

Clearance record

Decision date
Received
(127 days to decision)
Product code
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Standard Bariatrics, Inc. 4300 Glendale Milford Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXC

Trailing 12 months
1 clearance under product code OXC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OXC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260