STERILIZATION POUCH/ROLL MADE WITH TYVEK— 510(k) K133838

Name: FDA 510(k) clearance K133838
Creator: U.S. Food and Drug Administration
Published: 2015-03-11

Substantially Equivalent

Sigma Medical Supplies Corp.

FDA 510(k) clearance K133838 for STERILIZATION POUCH/ROLL MADE WITH TYVEK, Substantially Equivalent on 2015-03-11. Applicant: Sigma Medical Supplies Corp.. Device class: 2.

Clearance details

Applicant: Sigma Medical Supplies Corp.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2013-12-18
Decision date: 2015-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRG

view all

K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more2026-07-02
K252823 — Dukal Crepe Paper Sterilization Wrap2026-05-28
K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
K251347 — Sterilization Pouch/Roll2026-01-28
K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

More clearances from Sigma Medical Supplies Corp.

view all

K180661 — SIGMA Sterilization Pouch and Roll2018-06-05
K102158 — SIGMA STERILIZATION POUCH & ROLL2011-08-02

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.