510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102158Substantially Equivalent

Sigma Sterilization Pouch & Roll

Sigma Medical Supplies Corp., Kaohsiung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102158 is the FDA 510(k) clearance record for SIGMA STERILIZATION POUCH & ROLL, a class II device, cleared for Sigma Medical Supplies Corp. on under FDA product code FRG (Wrap, Sterilization). FDA records list 5 510(k) clearances for Sigma Medical Supplies Corp., from to . As of , FDA records show no recalls naming K102158.

Clearance record

Decision date
Received
(368 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Sigma Medical Supplies Corp. # 15-2, Ln. 26, Mineyuan 1st Rd., Kaohsiung, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260