510(k) K973943
- Device
- INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER
- Applicant
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- 510(k) number
- K973943
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-27
- Date received
- 1997-10-16
- 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
- ROBERT L CASARSA
- Address
- 353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 3011373951
- 3013497507
- 9614434
- 8044098
- 3014461810
- 3004142400
- 3027339877
- 3015539532
- 1720747
- 3003418325
- 3017210488
- 3006116468
- 8010298
- 2134944
- 3009763019
- 1718850
- 1221072
- 3013188547
- 8010591
- 3015335150
- 3015895145
- 3010305275
- 3013501671
- 3007703432
- 2032521
- 3011459664
- 3007111496
- 3013077751
- 3010370500
- 1018233
- 3009134855
- 1060680
- 3006498370
- 8010877
- 1225984
- 3008132398
- 3010605922
- 3031240334
- 9614945
- 3004111573
- 3015540957
- 3012995405
- 2523676
- 3005012805
- 3020331900
- 3021393544
- 2648727
- 3003435550
- 8010273
- 1222997
- 2242352
- 3004608878
- 1056128
- 3008383115
- 3010703925
- 9680837
- 3010055973
- 3010160527
- 3012883081
- 3007345416
- 3006581049
- 3002907620
- 2027111
- 1043214
- 3014848720
- 3009217531
- 1219930
- 3006897899
- 8040510
- 3010380518
- 3011401113
- 3011986317
- 3014579024
- 3012345110
- 3007487007
- 3008191256
- 3013155768
- 3011416394
- 3007791595
Source Documents#
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#
summary
FDA Review#
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