510(k) K183401
- Device
- Vis-U-All Low Temperature Sterilization Pouch/Tubing
- Applicant
- STERIS Corporation
- 510(k) number
- K183401
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-01
- Date received
- 2018-12-07
- Regulation
- 880.6850
- Classification name
- Wrap, Sterilization
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Nalepka
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 2182318
- 1423537
- 9680887
- 2410251
- 8010944
- 3006425876
- 3013410562
- 2183785
- 3012421755
- 9610612
- 3014456066
- 3007289408
- 2431273
- 2431166
- 3006847937
- 1051614
- 3010147274
- 3016851379
- 3013596742
- 3004080920
- 3004634710
- 3004201548
- 3009443860
- 9680357
- 3044322716
- 3008110533
- 1054380
- 3003495693
- 1418005
- 3005030944
- 2084725
- 3005599545
- 3009968482
- 9616088
- 2011171
- 3015895045
- 3010331645
- 3016218280
- 3018094310
- 2433012
- 3007339875
- 1221053
- 1054241
- 3001644167
- 1065597
- 3008770655
- 3005558160
- 3043051314
- 3013575574
- 3015633688
- 1032347
- 3019848304
- 9611959
- 1923569
- 3005061536
- 3008132392
- 3015231789
- 1319130
- 3017230778
- 2029015
- 2132509
- 2511556
- 1921846
- 3021010394
- 3036622014
- 3005180920
- 2523664
- 2024980
- 3007034244
- 2025102
- 3038718579
- 1055236
- 3014627756
- 3017949824
- 3010864832
- 2023811
- 2031508
- 1055892
- 8030607
Source Documents#
Other 510(k) Records For Product Code FRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 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 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024-10-07 |
| K241123 | Perpak™ Sterilization Tyvek Pouch | Km Corp. | 2024-09-18 |
Legacy Summary#
summary