510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082750Substantially Equivalent

Entact Septal Stapler, Model 610-00100

Entrigue Surgical, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082750 is the FDA 510(k) clearance record for ENTACT SEPTAL STAPLER, MODEL 610-00100, a class II device, cleared for Entrigue Surgical, Inc. on under FDA product code OLL (Septal Stapler/Absorbable Staples). FDA's definition for product code OLL reads: "To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing...". FDA records list 4 510(k) clearances for Entrigue Surgical, Inc., from to . As of , FDA records show no recalls naming K082750.

Clearance record

Decision date
Received
(109 days to decision)
Product code
OLL Septal Stapler/Absorbable Staples
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Entrigue Surgical, Inc. 12672 Silicon Dr. Suite 150, San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLL

Trailing 12 months

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

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