510(k) K872944
- Device
- LOOK SPRING-ASSIST SYRINGES
- Applicant
- LOOK, INC.
- 510(k) number
- K872944
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-04
- Date received
- 1987-07-28
- 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#
- 3022699058
- 2245304
- 3027534634
- 1067162
- 3013221738
- 3009595577
- 1060680
- 3035785623
- 1722458
- 9610921
- 9611024
- 9680597
- 3010041511
- 1219611
- 3010432890
- 3017494520
- 3014819517
- 3008727519
- 3004756837
- 3014165712
- 3010131137
- 9610847
- 3015173212
- 3026478941
- 3007895168
- 2030624
- 1724474
- 3004519921
- 3033589330
- 8010026
- 3027339877
- 1058602
- 2249062
- 3018681450
- 3010220595
- 1417485
- 2950467
- 3007384659
- 3012495575
- 8041187
- 3011749806
- 3017509841
- 9680425
- 3004142400
- 3007392007
- 3031983053
- 2032227
- 3013481097
- 3013187142
- 3007590959
- 9614279
- 3009039068
- 9615588
- 3005669815
- 3010175289
- 1313700
- 3006891665
- 2030598
- 3031259044
- 3002807090
- 3013023255
- 1526439
- 3009340644
- 3012551896
- 3003755939
- 1066491
- 1219930
- 3015058854
- 1720929
- 8031007
- 3005987567
- 3008496303
- 1920898
- 3006846316
- 3004192065
- 3013557562
- 3011689956
- 3016707060
- 9610993
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 |
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