510(k) K971202
- Device
- COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
- Applicant
- COMEG ENDOSKOPIE GMBH
- 510(k) number
- K971202
- Product code
- OCZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-27
- Date received
- 1997-04-01
- Regulation
- 876.1500
- Classification name
- Endoscopic Grasping/cutting Instrument, Non-powered
- 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
- PETER DUFFY
- Address
- 13790 E. Rice Pl. Aurora CO US 80015 80015
FDA Registration Numbers#
- 3006546082
- 8010487
- 1220592
- 1825146
- 3008573567
- 1047843
- 8010370
- 9610617
- 3007829657
- 3013440400
- 3010202439
- 8010047
- 1061927
- 3011270181
- 2011171
- 1222168
- 9611102
- 2020550
- 3004837686
- 3021023752
- 3014579161
- 2243757
- 1000343527
- 9614641
- 3008837339
- 2528981
- 3004447686
- 3011050570
- 3014342096
- 1056129
- 3012322232
- 3006621103
- 3011099779
- 2246552
- 3006696607
- 1643817
- 1820334
- 8010877
- 3017262662
- 9611594
- 2936485
- 3009217531
- 1528319
- 3008720584
- 3013460719
- 3014769442
- 3010707607
- 3009888344
Source Documents#
Other 510(k) Records For Product Code OCZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy | 2024-12-20 |
| K191900 | Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2020-03-27 |
| K152802 | Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016-01-21 |
| K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015-06-08 |
| K141058 | ENSIZOR ENDOSCOPIC SCISSORS | Slater Endoscopy, LLC | 2014-08-01 |
| K133736 | ENDOSCOPIC SUTURE CUTTER | United States Endoscopy Group, Inc. | 2014-01-07 |
| K120084 | ENDOSCOPIC RETRIEVAL DEVICE | United States Endoscopy Group, Inc. | 2012-05-30 |
| K103688 | G-PROX EZ ENDOSCOPIC GRASPER | Usgi Medical | 2011-01-14 |
| K101298 | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS | Endochoice, Inc. | 2010-08-05 |
| K072684 | MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM | Mondeal North America, Inc. | 2008-01-04 |
| K051276 | HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM | Richard Wolf Medical Instruments Corp. | 2005-10-28 |
| K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS | The Olympus Optical Co. | 2001-09-25 |
| K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | Telemed Systems, Inc. | 2001-04-02 |
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | Telemed Systems, Inc. | 1997-12-19 |
| K973071 | TRI TALON RETRIEVAL FORCEPS | Medical Engineering Laboratory, Inc. | 1997-10-24 |
Legacy Summary#
summary
FDA Review#
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