510(k) K951421
- Device
- GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
- Applicant
- GLOBAL MEDICAL PRODUCTS, LTD.
- 510(k) number
- K951421
- Product code
- FCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-16
- Date received
- 1995-03-28
- Regulation
- 876.1075
- Classification name
- Biopsy Needle
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD RYAN
- Address
- 2230 Nursery Rd. Unit D41 Clearwater FL US 34624 34624
FDA Registration Numbers#
- 3013557562
- 3016678045
- 3038356900
- 8010312
- 3010188783
- 3004749705
- 3005580113
- 2133772
- 3006849754
- 3016844398
- 3015077548
- 3000126629
- 3007748770
- 3017210488
- 1724474
- 3042940295
- 3015136750
- 9615480
- 3014769442
- 3007544634
- 1528319
- 3005099803
- 3008773560
- 3004904811
- 3010419931
- 1825146
- 9680269
- 1018233
- 3009337401
- 3012936513
- 1625685
- 3008044552
- 1037905
- 3002807314
- 1828132
- 3002806603
- 2183744
- 1417485
- 3012975098
- 3013462478
- 3009196578
- 3004837686
- 3011137372
- 1061124
- 3006950086
- 3030125051
- 3004111573
- 9617616
- 3030447506
- 3005012805
- 3033589330
- 1000393132
- 3029779285
- 3043585886
- 3044026004
- 9680794
- 3013440400
- 1000121056
- 2030624
- 3018094310
- 1221435
- 3011642792
- 9681260
- 3006788678
- 3001845648
- 9680904
- 2124215
- 2183456
- 9611612
- 9680809
- 1058584
- 3030446844
- 1222140
- 3006082230
- 3012536737
- 3015309643
- 3011050570
- 1211566
- 3015972753
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | 2026-07-24 |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024-07-29 |
| K231422 | Precision GI | Limaca Medical, Ltd. | 2023-08-28 |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 |
| K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023-05-30 |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023-03-29 |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2021-05-20 |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | 2020-01-29 |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | 2018-12-18 |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | 2018-11-15 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 |
Legacy Summary#
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
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