510(k) K962676
- Device
- DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
- Applicant
- UNITED STATES ENDOSCOPY GROUP, INC.
- 510(k) number
- K962676
- Product code
- FGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-04
- Date received
- 1996-07-09
- Regulation
- 876.4680
- Classification name
- Dislodger, Stone, Flexible
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEAN SECREST
- Address
- 9330 Progress Pkwy. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3006617533
- 3008808042
- 8010273
- 3007007790
- 3011137372
- 1047843
- 3010202439
- 2020550
- 9680001
- 3010041511
- 3032859397
- 3005099803
- 3005987240
- 2528981
- 3011050570
- 3010421104
- 1037955
- 2529846
- 2246552
- 2936485
- 9611503
- 1528319
- 3003289691
- 2124215
- 2183744
- 1519132
- 3003790304
Source Documents#
Other 510(k) Records For Product Code FGO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001563 | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET | Scion Cardiovascular, Inc. | 2000-11-22 |
| K970121 | STONE DISLODGER, BASKET | Boston Scientific Corp | 1997-04-02 |
| K963750 | RETRIEVAL SNARE | Boston Scientific Corp | 1996-11-22 |
| K951309 | STONE DISLODGER, BASKET | Boston Scientific Corp | 1995-05-17 |
| K933261 | GRASPING FORCEPS | Surgitek | 1994-01-11 |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Annex Medical, Inc. | 1994-01-07 |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | Critikon Company, LLC | 1993-05-17 |
| K922542 | GRASPING FORCEPS | Surgitek | 1992-08-19 |
| K914111 | METAL URETERAL BASKET STONE DISLODGER, HELICAL | Annex Medical, Inc. | 1992-02-28 |
| K914112 | METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE | Annex Medical, Inc. | 1992-02-28 |
| K914110 | GRASPING FORCEPS | Annex Medical, Inc. | 1992-02-28 |
| K896322 | CN GAURD, STERILE LATEX SURGICAL GLOVES | C.N. Technocrats | 1990-07-12 |
| K895080 | SURGICAL GLOVES | Jet Far Industries, Inc. | 1990-01-24 |
| K893522 | SURGEON'S GLOVES | Thai Fuji Latex Co., Ltd. | 1990-01-22 |
| K885168 | RUBENSTEIN URETERAL STONE FRAGMENT BRUSH | Boston Scientific Corp | 1989-09-08 |
Legacy Summary#
summary
FDA Review#
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