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#
- 3004748541
- 3005813597
- 3010220595
- 3030446844
- 3003213883
- 3013831261
- 3003644849
- 9613910
- 3005418651
- 1000379039
- 3004111573
- 3004552850
- 3042158672
- 2243757
- 1926681
- 3006059835
- 2431166
- 3006513362
- 3012542015
- 3001620590
- 3011497859
- 3036978610
- 3013503739
- 3014579161
- 3002090132
- 3027187888
- 3009217531
- 3003851906
- 1125612
- 3014233600
- 3009560891
- 3002761766
- 3013901429
- 9617248
- 1221826
- 3007137643
- 3029082594
- 9681540
- 1720747
- 3003877407
- 3022320321
- 3019530907
- 3012445994
- 2030624
- 8021788
- 3007583964
- 1928237
- 1722070
- 9681384
- 3009756153
- 3010726901
- 2518436
- 9680837
- 3042888274
- 8010427
- 3013528571
- 3008808049
- 3003674698
- 3004530184
- 2022648
- 3019784580
- 8040278
- 1316463
- 3010402691
- 3008770252
- 3012104670
- 9610691
- 3010202439
- 3007597038
- 3016734145
- 3010806653
- 9681246
- 8010939
- 9611102
- 8043903
- 3009747810
- 3019404837
- 3003800159
- 3003418325
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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