510(k) K223600
- Device
- Sterilization Wrap
- Applicant
- Wuhan Zonsen Medical Products Co., Ltd.
- 510(k) number
- K223600
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-25
- Date received
- 2022-12-02
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Linna Ye
- Address
- No 8 Jinchao Rd., Zhucheng St. Wuhan CN
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
- 3012421607
- 3013596742
- 2511556
- 3005599545
- 3013410562
- 2523320
- 3010363542
- 1723170
- 2029015
- 3016096096
- 3006973666
- 3019848304
- 9680887
- 1417592
- 2431166
- 1724474
- 2084725
- 3009219448
- 3012421755
- 1828464
- 1527607
- 3007289408
- 3013443304
- 3009307523
- 3014456066
- 1054380
- 3005558160
- 1221053
- 1056276
- 1220246
- 8030672
- 3034393266
- 3012494290
- 2320762
- 2024312
- 1921846
- 1065597
- 3035642068
- 3015058854
- 3016426851
- 2435946
- 3006400329
- 3004970050
- 3016761372
- 3024787345
- 3008887731
- 3012892649
- 3009443860
- 3014683120
- 1923569
- 2183301
- 9611959
- 1418005
- 1217231
- 3038718579
- 8010944
- 3008559238
- 3036679484
- 3042191618
- 3042285072
- 3008489813
- 9616088
- 3017949824
- 3018047916
- 3009750712
- 1032347
- 3015068387
- 1526531
- 2433012
- 3006723155
- 3010147274
- 1836161
- 3008132392
- 3003604053
- 3013575574
- 3017910185
- 3008572101
- 3014421917
- 3004634710
- 3004080920
- 1053306
- 9613277
- 3017220525
- 1054241
- 2410251
- 9680794
- 3016678045
- 3021010394
- 3011279497
- 3043226252
- 3001644167
- 1527185
- 8030607
- 3007339875
- 1017294
- 9680357
- 9680031
- 9616872
- 8030674
- 3007046497
- 3013187142
- 9616096
- 2011171
- 3021013267
- 9615270
- 3016851379
- 3018094310
- 3003418325
- 1320894
- 3011497662
- 3010598169
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |