FLASHPAK— 510(k) K113776

Clearance details

Applicant

Symmetry Medical

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2011-12-22

Decision date

2012-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

New Bedford, MA, US

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• 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

• K122263 — 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE2012-09-28

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 →

• Z-1010-2017 — symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization containerClass II·Terminated·Symmetry Surgical, Inc.·20161129
• Z-1011-2017 — symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization containerClass II·Terminated·Symmetry Surgical, Inc.·20161129
• Z-1012-2017 — symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization containerClass II·Terminated·Symmetry Surgical, Inc.·20161129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113776.