510(k) K820302
- Device
- SURGIPEEL SELF-SEAL PACKAGING SYSTEM
- Applicant
- SURGICOT, INC.
- 510(k) number
- K820302
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-24
- Date received
- 1982-02-04
- Regulation
- 880.6850
- Classification name
- Wrap, Sterilization
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2523320
- 3012345110
- 9611959
- 2248608
- 9680357
- 3043051314
- 3013298431
- 2648727
- 1220246
- 3012421755
- 3015058854
- 3016426851
- 3016761372
- 3009219448
- 1320894
- 3010864832
- 9616872
- 3006723155
- 3017220525
- 3006400329
- 3005599545
- 3016096096
- 3011533888
- 2183785
- 1723170
- 3016928862
- 2431166
- 3011497662
- 3018047916
- 2523664
- 2433012
- 1527185
- 1834190
- 3015068387
- 3015633688
- 3036679484
- 3008887731
- 3003418325
- 3012315097
- 1032347
- 2029015
- 3007046497
- 3007289408
- 3013443304
- 1043644
- 8030607
- 3027977504
- 3008572101
- 9616088
- 3015895045
- 3038718579
- 1065597
- 1055236
- 3011279497
- 8022129
- 3007743883
- 3021010394
- 3012477813
- 1030451
- 2024980
- 9680031
- 3014421917
- 3007539307
- 3009307523
- 3005748481
- 2023811
- 3018094310
- 1043214
- 1319130
- 1418005
- 3005558160
- 3009968482
- 2025102
- 1221053
- 3012421607
- 3024088964
- 3004201548
- 3008110533
- 3034393266
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | 2026-07-02 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026-05-28 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | 2026-05-18 |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026-01-28 |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025-10-31 |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025-06-06 |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | 2025-04-04 |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | 2024-11-04 |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases