510(k) K810646
- Device
- OR/CS WRAP
- Applicant
- AMERICAN THRESHOLD INDUSTRIES, INC.
- 510(k) number
- K810646
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-20
- Date received
- 1981-03-10
- 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#
- 9680031
- 1051614
- 9616088
- 2433012
- 3009443860
- 3004143450
- 3011497662
- 3013298431
- 3002579136
- 3015633688
- 8030607
- 3021010394
- 1320894
- 3027977504
- 8022129
- 3008572101
- 3006973666
- 3014421917
- 1526531
- 3036622014
- 3010864832
- 3017220525
- 1832228
- 1032227
- 3035642068
- 3010331645
- 3012477813
- 3011059079
- 3017113900
- 2182318
- 3018781093
- 3045855232
- 3008770655
- 1834190
- 3004634710
- 3005061536
- 3007339875
- 1724474
- 3021013267
- 3043226252
- 3024088964
- 3042285072
- 3012892649
- 3004488394
- 2916714
- 3009307523
- 3027234828
- 3015058854
- 3007034244
- 3038718579
- 3016218280
- 3018094310
- 3004193466
- 3015895045
- 1220246
- 9616096
- 2320762
- 9616872
- 3004753358
- 3004362278
- 1836161
- 3017910185
- 3005030944
- 3016928862
- 2431273
- 3011877754
- 1054380
- 3008110533
- 1043644
- 3013443304
- 3013410562
- 3019848304
- 1043214
- 3009219448
- 3016075971
- 3013187142
- 1319130
- 3038191347
- 3013596742
- 1056276
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