PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)— 510(k) K252098

Name: FDA 510(k) clearance K252098
Creator: U.S. Food and Drug Administration
Published: 2026-02-18

Substantially Equivalent

Methyl Co., Ltd.

FDA 510(k) clearance K252098 for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED), Substantially Equivalent on 2026-02-18. Applicant: Methyl Co., Ltd.. Device class: 2.

Summary

Methyl Co.'s PA3X Detachable Safety Sleeve Syringe (with needle) lists two designations, SC-23ED and SD-23ED, under product code MEG, antistick syringe. The record doesn't say how they differ.

Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).

Methyl filed from Taipei, Taiwan. FDA found it substantially equivalent 230 calendar days after receipt (July 3, 2025 to February 18, 2026).

Clearance details

Applicant: Methyl Co., Ltd.
Product code: Product code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-07-03
Decision date: 2026-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEG

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K250847 — VaporShield2025-12-12
K230287 — SaviSafe Safety Device2023-11-21
K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
K231907 — Medline Safety Insulin and TB Syringes2023-10-18
K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more2023-06-21

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.