510(k) K882536
- Device
- OPHTHALMIC PAO VALVE
- Applicant
- LOOK, INC.
- 510(k) number
- K882536
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-09
- Date received
- 1988-06-21
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID H BARRETT
- Address
- 45 Charles Park Rd. Boston MA US 02132 02132
FDA Registration Numbers#
- 3003310007
- 3013176080
- 3011749806
- 3005609751
- 3013162291
- 3047706961
- 3014165712
- 9617544
- 9610921
- 3009551627
- 2029275
- 3004111573
- 3010462274
- 3006787036
- 3017907716
- 1917413
- 1017768
- 3004458481
- 3013466775
- 3004143450
- 3017509841
- 2032098
- 3006891665
- 2249915
- 9610993
- 3016831076
- 3015727296
- 3036978618
- 9610847
- 3004519921
- 3009746425
- 2024024
- 3003589279
- 2530154
- 3011453824
- 3019004087
- 3015542154
- 9614279
- 3007007790
- 3009417901
- 3018326554
- 1647137
- 3012552122
- 3008496303
- 1061124
- 3015910259
- 1219205
- 1915484
- 1420054
- 1320894
- 3010515547
- 8031563
- 9613304
- 1055236
- 9614033
- 3020704423
- 3010384323
- 3019807891
- 3005813632
- 1067162
- 8041145
- 3013557562
- 3013404959
- 3010131137
- 3005246939
- 1423537
- 3010321647
- 3036679495
- 2183744
- 3004099493
- 1423929
- 3002806603
- 1423662
- 3008650117
- 3004431266
- 2950467
- 3010026090
- 3015176887
- 2025816
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
Legacy Summary#
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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