510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090821Substantially Equivalent

Chex Single Use Curved Intraluminal Circular Stapler, Model Cs 21, Cs 25, Cs 28, Cs 32, Cs 21L, Cs 25L, Cs 28L, Cs 32L

Frankenman International Limited, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090821 is the FDA 510(k) clearance record for CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L, a class II device, cleared for Frankenman International Limited on under FDA product code GDW (Staple, Implantable). FDA records list one 510(k) clearance for Frankenman International Limited. As of , FDA records show no recalls naming K090821.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Frankenman International Limited 1705 S. Capital Of Hwy., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260