510(k) K253978
- Device
- Universal Seal (5-12 mm)
- Applicant
- Intuitive Surgical, Inc.
- 510(k) number
- K253978
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-24
- Date received
- 2025-12-12
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Taian Chen
- Address
- 1266 Kifer Rd. Sunnyvale CA US 94086 94086
FDA Registration Numbers
- 3002808148
- 1450662
- 3020142503
- 3030926959
- 3007593944
- 1416980
- 3011459664
- 3011277660
- 9614969
- 3004464325
- 2031917
- 1421101
- 3015453963
- 2183744
- 3013188547
- 3009039068
- 3023852420
- 3008805497
- 1216677
- 9612074
- 3030311186
- 2938071
- 2032521
- 2649614
- 3004434200
- 3030447506
- 3001556604
- 1643264
- 3011050570
- 3043225236
- 2085947
- 1423537
- 3031238646
- 8044098
- 1718850
- 3008843439
- 3010305275
- 2028523
- 3027339877
- 8010877
- 3017210488
- 8010487
- 3002807314
- 3003915875
- 3011416394
- 2916714
- 3010860245
- 2424366
- 3030733800
- 9616067
- 3007305485
- 3004530184
- 3010331645
- 3004378299
- 3009212837
- 2135348
- 3030839824
- 3014279513
- 8010591
- 3006116468
- 9613793
- 9710524
- 3015173212
- 3007421149
- 3006638824
- 3009134855
- 3043152784
- 3029950834
- 3003687489
- 3014579161
- 3014579024
- 3006897899
- 9680837
- 3014202166
- 8010418
- 1061927
- 3008040391
- 3010612620
- 3005595283
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code GCJ
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|---|---|---|---|
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| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 |
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| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025-10-20 |