510(k) K072912
- Device
- SOPRO 225 DUAL HALOGEN LIGHT SOURCE
- Applicant
- SOPRO
- 510(k) number
- K072912
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-16
- Date received
- 2007-10-12
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE SALESKY
- Address
- 124 Gaither Dr. Suite #140 Mt. Laurel NJ US 08054 08054
FDA Registration Numbers#
- 3016851379
- 1650907
- 8043548
- 1820334
- 1828132
- 3004464325
- 1000121056
- 3010860245
- 1718850
- 3013557562
- 3016727307
- 9612086
- 1450997
- 1222997
- 3013944123
- 3006082230
- 3021744379
- 3003775006
- 8010047
- 3012470322
- 1221934
- 3004491689
- 3011401113
- 3005075853
- 3021226419
- 3011024991
- 9611594
- 3020899789
- 3007185043
- 9612075
- 2135348
- 3001556604
- 3011270181
- 2210968
- 2011171
- 1423662
- 3005254598
- 3010806467
- 3043152784
- 3042940623
- 3000237660
- 3012453745
- 3012507533
- 3005636544
- 2938071
- 1928237
- 1223422
- 3001722928
- 3009889060
- 3008770252
- 3006897899
- 1056350
- 3015183635
- 9681834
- 3005099803
- 3043225236
- 9615782
- 8044057
- 8010273
- 1211566
- 3016607092
- 2528981
- 3015335150
- 3011221476
- 3015336263
- 1825146
- 3006638824
- 3030926959
- 8010697
- 3015532525
- 3011063460
- 3004091527
- 3011936016
- 3018094310
- 1416980
- 3012322232
- 3008040391
- 3011052945
- 3003139373
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | 2026-08-13 |
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | 2026-07-24 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | 2026-06-11 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
Legacy Summary#
summary
FDA Review#
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