510(k) K240330
- Device
- HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
- Applicant
- O&M Halyard, Inc.
- 510(k) number
- K240330
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-07
- Date received
- 2024-02-05
- 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
- N
Related Records
Applicant Contact
- Contact
- Anureet Singh
- Address
- 9120 Lockwood Blvd. Mechanicsville VA US 23116 23116
FDA Registration Numbers
- 3044322716
- 3004488394
- 1834190
- 3005180920
- 3015895045
- 3004362278
- 1043644
- 1032227
- 3038138452
- 2523664
- 3005748481
- 3008770655
- 3011059079
- 9680845
- 3029802606
- 1030451
- 3007539307
- 3015140351
- 3006847937
- 2023811
- 3015820879
- 3002579136
- 3017230778
- 3027977504
- 3004133257
- 3004201548
- 3005061536
- 3042367543
- 1319130
- 2182318
- 3038191347
- 1643264
- 2648727
- 2025102
- 3013557562
- 1051614
- 8022129
- 9610612
- 3014627756
- 3027234828
- 1423537
- 3003495693
- 3017498782
- 2437780
- 3015633688
- 3006425876
- 3004143450
- 3012345110
- 3004193466
- 2242656
- 3013298431
- 2183287
- 2031508
- 2431273
- 3010864832
- 2916714
- 3043051314
- 3007034244
- 1832228
- 3009968482
- 3036622014
- 2024980
- 3005030944
- 3021361802
- 3016075971
- 3016928862
- 3011533888
- 3010331645
- 3016218280
- 3004753358
- 1055892
- 3008110533
- 1043214
- 2248608
- 3018781093
- 2183785
- 3015231789
- 3012315097
- 1055236
Source Documents
Other 510(k) Records For Product Code FRG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024-09-17 |