510(k) K905117
- Device
- ENDOSCOPE AND ACCESSORIES
- Applicant
- NORTHGATE TECHNOLOGIES, INC.
- 510(k) number
- K905117
- Product code
- GCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-25
- Date received
- 1990-11-13
- Regulation
- 876.1500
- Classification name
- Laryngoscope, Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAMUELLA D EMRICH
- Address
- 3930 Ventura Dr. Arlington Heights IL US 60004 60004
FDA Registration Numbers#
- 3021632375
- 3013557562
- 1055236
- 3017636737
- 3010202439
- 2020550
- 1648701
- 1018470
- 3001675293
- 3015612252
- 9612501
- 1043214
- 3014279513
- 3018094310
- 1219930
- 3014479313
- 2320762
- 1054241
- 3014461810
- 3009380063
- 9680718
- 3017210488
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021747 | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR | Surgicon, Inc. | 2002-08-15 |
| K003222 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Computer Motion, Inc. | 2000-11-03 |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Karl Storz Imaging, Inc. | 2000-07-17 |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933515 | BOOTY ENDOSCOPE WARMER | T-Med, Inc. | 1993-10-27 |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | Birtcher Medical Systems, Inc. | 1993-04-20 |
| K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | United States Surgical, A Division of Tyco Healthc | 1993-02-01 |
| K920139 | GLEESON CLOT-BUSTER | Conmedcorp | 1992-04-15 |
| K915762 | POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1992-03-13 |
| K914120 | SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT | Conmedcorp | 1991-10-30 |
| K911829 | ENDOSTAPLE | ETHICON, Inc. | 1991-08-28 |
| K911461 | SURGITRON | Ellman Intl. Mfg., Inc. | 1991-04-25 |
| K896205 | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE | Dexide, Inc. | 1990-03-22 |
Legacy Summary#
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FDA Review#
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