510(k) K803204
- Device
- IRRIGATION PISTON
- Applicant
- WALPAK CO.
- 510(k) number
- K803204
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-01-21
- Date received
- 1980-12-17
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009761558
- 1213809
- 3013557562
- 9611024
- 1061124
- 1060680
- 3012261967
- 3009888344
- 3004082685
- 9616157
- 3014315664
- 9610048
- 3015539532
- 3003681915
- 3010026090
- 1832816
- 3012833053
- 3012410077
- 2029214
- 3036722184
- 3000779542
- 1417485
- 1222747
- 1043534
- 1064371
- 3017770710
- 3013561817
- 3008789114
- 3003152976
- 9614279
- 1416980
- 1019003
- 9617594
- 8040619
- 3030201489
- 3015231789
- 1420054
- 3009746061
- 2433012
- 1423537
- 2518902
- 3010321647
- 3009742443
- 9611594
- 3009302820
- 3005798905
- 3008272066
- 3002907620
- 3014747754
- 9610993
- 3012883081
- 1055236
- 3003755939
- 3034676720
- 2950190
- 3010405396
- 1018470
- 1000484830
- 1219655
- 9680425
- 9615588
- 3006142663
- 3000126234
- 3001124136
- 3017208642
- 3010221586
- 3014819517
- 3016965628
- 3005301868
- 1721504
- 3005202235
- 1054241
- 3015724078
- 3004496829
- 3013517171
- 3033509898
- 3003595336
- 3008719222
- 3004605321
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#
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
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