510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123128Substantially Equivalent

Seri Surgical Scaffold

Allergan, Medford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123128 is the FDA 510(k) clearance record for SERI SURGICAL SCAFFOLD, a class II device, cleared for Allergan on under FDA product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery). FDA's definition for product code OXF reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". FDA records list 39 510(k) clearances for Allergan, from to . As of , FDA records show no recalls naming K123128.

Clearance record

Decision date
Received
(203 days to decision)
Product code
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Allergan 200 Boston Ave., Medford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXF

Trailing 12 months

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

FDA records show no clearances under product code OXF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXF, 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