510(k) K973415
- Device
- CURVILINEAR SUTURE PLACEMENT SYSTEM
- Applicant
- LAURUS MEDICAL CORP.
- 510(k) number
- K973415
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-02
- Date received
- 1997-09-09
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A BASLER
- Address
- 10 Chrysler, Suite B Irvine CA US 92618 92618
FDA Registration Numbers#
- 3008044552
- 3024137003
- 3012453745
- 3029968414
- 3042940623
- 2320762
- 1320468
- 3009763019
- 3011401113
- 3042225166
- 3008202779
- 9614209
- 1037955
- 9681260
- 3003935342
- 3003915875
- 3014615697
- 3016804805
- 3011063460
- 8010422
- 3025598220
- 3012345110
- 3001003398
- 9616088
- 2518897
- 3008805497
- 3009161688
- 3009756153
- 9612030
- 3011782009
- 3013445147
- 3010043098
- 3010120217
- 1017294
- 3030626857
- 2529647
- 1649518
- 1123010
- 3010590422
- 3045816907
- 3002808148
- 8010273
- 9610612
- 8043971
- 9614434
- 2025816
- 2032098
- 3031594238
- 3006546082
- 3010305275
- 1222773
- 3010157088
- 2135348
- 3002579136
- 9613846
- 3013557562
- 2431166
- 3014461810
- 3033902430
- 9680721
- 3010177712
- 3003755939
- 1650907
- 3007593944
- 3017262662
- 2648727
- 3010370500
- 1123137
- 3030311186
- 3003604053
- 2032112
- 3015453963
- 3015335150
- 3004044817
- 1836161
- 3016832577
- 2183744
- 3010220244
- 3035366890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
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