Product code FRG— General Hospital
DURABLUE STERILIZATION WRAP
- Classification name
- Wrap, Sterilization
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Total cleared
- 323
- First cleared
- Most recent
Market context for product code FRG
FDA has cleared devices under product code FRG between 1976 and 2026, filed by 177 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code FRG
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FRG
1–100 of 323- K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more
- K252823 — Dukal Crepe Paper Sterilization Wrap
- K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more
- K251347 — Sterilization Pouch/Roll
- K251177 — Self-Seal Sterilization Pouch and Roll
- K250306 — Chex-All Sterilization Pouches and Tubes
- K243179 — Sterilization Pouch and Roll
- K250321 — GCI Sterilization Wrappers
- K243721 — Self Sealing Sterilization Pouches
- K250011 — Turbett Surgical Instrument Pod (3 models)
- K241565 — Sterilization Package/Reel
- K242898 — Sterilization Pouches and Reels
- K243431 — Medicom Sterilization Pouch and Reel
- K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
- K242839 — Safe Secure Sterilization Pouches and Rolls
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K241123 — Perpak Sterilization Tyvek Pouch
- K234132 — Medline Reusable Sterilization Wrappers
- K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
- K240330 — HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
- K240862 — Medicom Sterilization Wrap
- K232625 — Steriking® Pouch for Robotic Instruments
- K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K233262 — Dukal SMS Sterilization Wrap
- K230137 — Reliance® Fusion Sterilization Wraps
- K231996 — Steriking® LT-Blueline Pouches with Tyvek®
- K231999 — Steriking® LT-Blueline Pouches with Tyvek®
- K223600 — Sterilization Wrap
- K231500 — Vis-U-All Low Temperature Sterilization Pouches
- K223025 — Tyvek Roll with CI for STERLINK Sterilizer
- K222151 — Sterilization Wrap
- K221875 — Sterilization Pouch and Roll
- K221379 — Steriking LT-Blueline Pouches with Tyvek
- K221377 — SteriKing LT-Blueline Pouches with Tyvek
- K220365 — Gemini Sterilization Wrap
- K222440 — Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
- K191131 — Solidence Multipockets
- K214007 — HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
- K221016 — Steriking Packaging for Medical Devices
- K213907 — CareGUARD Sterilization Wrap
- K220133 — Sterilization Wraps
- K210810 — Steiking Packaging for Medical Devices
- K212338 — SterileRight sterilization pouch and roll
- K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer
- K202593 — Turbett Instrument Pod
- K202462 — SIGMA Sterilization Pouch and Roll
- K200335 — Sterisheet Sterilization Wrap
- K200336 — Tyvek Sterilization Pouches with Chevron Seal
- K200240 — Turbett Instrument Pod
- K193561 — Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
- K192641 — Gemini Titan Sterilization Wrap
- K182184 — Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
- K192147 — Halyard ONE-STEP* Sterilization Wrap
- K183356 — Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
- K181957 — Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
- K182656 — JAMBRO Single Core A Sterilization wrap
- K181959 — HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
- K183401 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K180139 — Safe Secure Sterilization Pouches and Rolls
- K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K181174 — Cardinal Health Sterilization Wrap
- K172280 — BH Sterilization Pouch
- K180672 — Sterilization Pouch/Roll Made with Tyvek
- K180661 — SIGMA Sterilization Pouch and Roll
- K172749 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K170437 — Sterisheet Sterilization Wrap
- K170429 — Tyvek Sterilization Pouches with Chevron Seal
- K162362 — PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
- K172207 — Standard Supreme Sterilization Wrapper
- K171533 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K162993 — Gemini Sterilization Wrap
- K162258 — Self Sealing Sterilization Pouches
- K161910 — Cardinal Health Sterilization Wrap
- K161415 — SteriTite Containers System & MediTray Products
- K160595 — PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
- K162162 — Barrier Supreme Sterilization Wrapper
- K153540 — Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
- K160755 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
- K160908 — Vis-U-All Low Temperature Sterilization Pouch/Tubing
- K152564 — Gemini Sterilization Wrap
- K152458 — Gemini Bonded Sterilization Wrap
- K152669 — PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
- K153025 — Turbett Surgical Container
- K151445 — Cardinal Health Sterilization Wrap
- K152291 — Sterisheet Sterilization Wrap
- K150698 — Gemini Sterilization Wrap
- K152058 — Tyvek Sterilization Pouches with Chevron Seal
- K151788 — Cardinal Health Sterilization Wrap
- K143117 — Wire Sterilization Package with Indicators
- K143637 — U&U Sterilization Pouch and Roll
- K143147 — Gemini Bonded Sterilization Wrap
- K143053 — KIMGUARD ONE-STEP Sterilization Wrap
- K141826 — FLASHPAK STERILIZATION CONTAINER SYSTEM
- K133838 — STERILIZATION POUCH/ROLL MADE WITH TYVEK
- K142782 — KIMGUARD ONE-STEP Sterilization Wrap
- K141693 — Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
- K141712 — KIMGUARD ONE STEP STERILIZATION WRAP
- K141412 — STERILUCENT SELF-SEAL STERILIZATION POUCH
- K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP
- K141612 — KIMGUARD ONE-STEP STERILIZATION WRAP
Data sourced from openFDA. This site is unofficial and independent of the FDA.