Pro-Guard Double-Duty Sterilization Wrap (Single Use)
FDA 510(k) K962605 · Surgicot, Inc.
510(k) numberK962605
Submission
- Device name
- Pro-Guard Double-Duty Sterilization Wrap (Single Use)
- Applicant
- Surgicot, Inc.
Research Triangle Park, NC, US - Received
- July 2, 1996
- Decision date
- March 11, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
More from Turbett Surgical
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| K931270 | Surgiclean Enzymatic Instrument CleanerFLG · Traditional | 04/13/1994SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | 07/17/1986SE |
| K854631 | Assert Eo Biological Test PackFRC · Traditional | 05/27/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | 05/20/1986SE |
| K840541 | Neuro SpongeGDY · Traditional | 04/23/1984SE |
| K840471 | Eye SpearHOZ · Traditional | 03/16/1984SE |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | 03/12/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
| K820302 | Surgipeel Self-Seal Packaging SystemFRG · Traditional | 02/24/1982SE |
Questions and answers
When was Pro-Guard Double-Duty Sterilization Wrap (Single Use) cleared by the FDA?
Pro-Guard Double-Duty Sterilization Wrap (Single Use) (K962605) received a 510(k) decision of Substantially Equivalent on March 11, 1997, 252 days after the submission was received.
What is the product code of K962605?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.