510(k) K162362
- Device
- PMSSteripack Flat Sterilization Pouch (FP) And Roll (FL) With Chemical Indicator
- Applicant
- PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS
- 510(k) number
- K162362
- Product code
- FRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-13
- Date received
- 2016-08-23
- 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
- DERYA DIKICI
- Address
- Karaduvar Mah.Serbest Bolge, 11.Cad #46 Mersin Serbest Bolgesi, Akdeniz Mersin TR 33020 33020
FDA Registration Numbers#
- 3012421607
- 2183301
- 9616088
- 2248608
- 3013596742
- 3005558160
- 9680845
- 3010331645
- 3004080920
- 1032347
- 3017220525
- 1828464
- 8010944
- 3027234828
- 3015068387
- 3011497662
- 1319130
- 3014627756
- 3038191347
- 3013187142
- 3006425876
- 3004143450
- 3016678045
- 9611959
- 3007539307
- 3021013267
- 2183785
- 1220246
- 3012421755
- 3014456066
- 3015058854
- 2648727
- 3042285072
- 3038718579
- 3029802606
- 3006400329
- 1053306
- 2242656
- 1526531
- 3005030944
- 2011171
- 3016075971
- 3001644167
- 3013298431
- 3015895045
- 3005599545
- 3016851379
- 3027977504
- 9680887
- 3015140351
- 3004488394
- 3036622014
- 3012892649
- 1417592
- 3004122598
- 2435946
- 3015231789
- 2410251
- 3003495693
- 3044322716
- 3043226252
- 1724474
- 8030672
- 3013410562
- 3024787345
- 3014683120
- 3013557562
- 3004193466
- 3010864832
- 2023811
- 3010363542
- 1056276
- 2511556
- 3008559238
- 3007034244
- 3016426851
- 3006847937
- 1723170
- 3004362278
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 |
| 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 |
Legacy Summary#
summary
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