510(k) K261897
- Device
- 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
- Applicant
- O&M Halyard, Inc.
- 510(k) number
- K261897
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-02
- Date received
- 2026-06-05
- 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
- Y
Applicant Contact#
- Contact
- Anureet Singh
- Address
- 1220 Old Alpharetta Rd. Alpharetta GA US 30022 30022
FDA Registration Numbers#
- 3042191618
- 3021013267
- 3008559238
- 3021361802
- 3009219448
- 1527607
- 3005061536
- 3010598169
- 2025102
- 3005748481
- 3012421755
- 2182318
- 3006425876
- 1032347
- 3004143450
- 3042285072
- 1921846
- 3003495693
- 1724474
- 2242656
- 3016678045
- 3005180920
- 1423537
- 3016761372
- 3007046497
- 3018047916
- 2084725
- 3044819802
- 3013410562
- 3017949824
- 3011059079
- 3004133257
- 3015633688
- 8010944
- 9680794
- 3014627756
- 2011171
- 3003418325
- 3018094310
- 3004362278
- 3015895045
- 3005030944
- 3006723155
- 8030607
- 3012345110
- 8022129
- 3024787345
- 3007743883
- 3010147274
- 3013596742
- 1017294
- 3013575574
- 3017498782
- 3013187142
- 3017113900
- 1053306
- 3017230778
- 3007289408
- 3042367543
- 1043214
- 1526531
- 1834190
- 3044322716
- 9616088
- 1217231
- 3012421607
- 3004488394
- 3014421917
- 9680031
- 2183287
- 3029802606
- 2523320
- 3036622014
- 2437780
- 1527185
- 1032227
- 1832228
- 3013298431
- 3043226252
- 2511556
Source Documents#
Other 510(k) Records For Product Code FRG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | 2024-10-07 |