510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101378Substantially Equivalent

Frankenman Surgical Staplers

Suzhou Frankenman Medical Equipment Co., Ltd., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101378 is the FDA 510(k) clearance record for FRANKENMAN SURGICAL STAPLERS, a class II device, cleared for Suzhou Frankenman Medical Equipment Co., Ltd. on under FDA product code GDW (Staple, Implantable). FDA records list one 510(k) clearance for Suzhou Frankenman Medical Equipment Co., Ltd. As of , FDA records show no recalls naming K101378.

Clearance record

Decision date
Received
(43 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Suzhou Frankenman Medical Equipment Co., Ltd. 1705 S. Capital Of Texas 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