510(k) K043605
- Device
- INSCOPE 3-STAGE BALLOON DILATOR
- Applicant
- CORDIS EUROPA, N.V.
- 510(k) number
- K043605
- Product code
- KNQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-04
- Date received
- 2004-12-30
- Regulation
- 876.5365
- Classification name
- Dilator, Esophageal
- 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
- HARM HOVINGA
- Address
- Oosteinde 8 Roden, Drenthe NL NL-9301 LJ NL-9301 LJ
FDA Registration Numbers#
- 2183744
- 3009106214
- 3017210488
- 3033434906
- 2528981
- 9616684
- 1220477
- 3004837686
- 3015309643
- 1223925
- 3010288205
- 3006950086
- 1320894
- 3016789487
- 1222168
- 3004730544
- 3021009035
- 3008720584
- 3010273872
- 2183446
- 3011347300
- 3006750742
- 3003790304
- 3033589330
- 3009018440
- 2124215
- 3009217531
- 3005099803
- 3002807314
- 3007305485
- 3010138349
- 1016427
- 1721676
- 1721504
- 1000121056
- 3017103427
- 3010011359
- 1037905
- 3021632375
- 3011050570
- 1724474
- 1000393132
- 1643817
- 3013526170
- 1820334
- 3015225571
- 1528319
- 3011137372
- 3012494290
- 3013440400
- 2126666
- 3012536737
- 3013557562
- 9681260
- 3042872931
- 3006696607
- 3010041511
Source Documents#
Other 510(k) Records For Product Code KNQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122924 | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | 2012-10-24 |
| K093236 | ETHICON ENDO-SURGERYOPTICAL DILATOR | Ethicon Endo-Surgery, Inc. | 2009-11-10 |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | Cook Endoscopy | 2009-09-25 |
| K082995 | SMART DILATOR | Safestitch Medical | 2009-02-06 |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | Cook Endoscopy | 2006-12-01 |
| K061787 | MAXFORCE TTS SINGLE-USE BALLOON DILATOR | Boston Scientific Corp | 2006-09-21 |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | 2006-04-11 |
| K033936 | BARD ELIMINATOR PET BALLOON DILATORS | C.R. Bard, Inc. | 2004-01-14 |
| K031147 | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR | Ethicon Endo-Surgery, Inc. | 2004-01-12 |
| K023907 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER | Cordis Corp. | 2002-12-18 |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Medovations, Inc. | 2000-11-01 |
| K993720 | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER | Cordis Corp. | 2000-01-18 |
| K983373 | IMPACT BALLOON DILATION CATHETER | B. Braun/Mcgaw | 1999-06-22 |
| K990935 | JACKSON ESOPHAGEAL DILATOR | Pilling Weck Surgical | 1999-05-17 |
| K974788 | CRE(TM) BALLOON DILATATION CATHETER | Boston Scientific Corp | 1998-03-20 |
Legacy Summary#
summary
FDA Review#
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