510(k) K191602
- Device
- APA Oxy Blade
- Applicant
- Venner Medical (Singapore) Pte Ltd
- 510(k) number
- K191602
- Product code
- CCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-08-02
- Date received
- 2019-06-17
- Regulation
- 868.5540
- Classification name
- Laryngoscope, Rigid
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Adrian P. Waterton
- Address
- 35 Joo Koon Cir. Singapore SG 629110 629110
FDA Registration Numbers#
- 9614069
- 2020550
- 9611102
- 3015895045
- 9616250
- 1836161
- 3006061749
- 3007751820
- 3012797688
- 3014129616
- 3008264111
- 3003759558
- 3045010519
- 2244478
- 3012445994
- 3032747418
- 3005067367
- 9613926
- 2529846
- 3023657851
- 3027655341
- 3005698350
- 3009429841
- 3015143057
- 3009703496
- 9610691
- 3011371465
- 3003882387
- 3008693658
- 3002090132
- 3008520150
- 3010353847
- 3010042047
- 3027187888
- 3019530907
- 3003807268
- 3009756153
- 3027847726
- 3016195092
- 3009340886
- 3006389770
- 8010427
- 9680002
- 3021031769
- 3025349182
- 3010676356
- 3010272829
- 3003761012
- 3007647244
- 2030624
- 3030839824
- 2080783
- 3008338766
- 3004552850
- 3016678045
- 3030516433
- 3017202422
- 3004111573
- 3004748541
- 3004863697
- 3005528784
- 3003418325
- 9680244
- 3019404837
- 9614093
- 3021666757
- 8043903
- 3015173212
- 1519132
- 3042158672
- 3004608878
- 3014498758
- 3003213883
- 8010704
- 3013557562
- 3006455037
- 3002675176
- 3013831261
- 8010099
Source Documents#
Other 510(k) Records For Product Code CCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | 2017-06-22 |
| K140951 | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | 2014-11-10 |
| K121378 | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | 2012-06-21 |
| K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | 2007-02-09 |
| K062523 | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | 2006-11-17 |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 | Minrad, Inc. | 2006-08-31 |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Minrad, Inc. | 2006-08-31 |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Minrad, Inc. | 2004-11-15 |
| K984101 | FLEXIBLADE | Arco Medic , Ltd. | 1999-09-03 |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | 1998-04-30 |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE | Wilson Greatbatch Technologies, Inc. | 1997-11-19 |
| K945590 | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
| K961832 | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | 1996-09-06 |
| K945301 | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | 1996-05-31 |
| K954787 | ILLUMINATOR | Hospitak, Inc. | 1996-01-31 |
Legacy Summary#
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FDA Review#
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